[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-drug-interaction-ddi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-drug-interaction-ddi":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,51,84,113,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100452820","phase-1-study-of-zanzalintinib-in-combination-with-immuno-oncology-or-other-agents-in-participants-with-solid-tumors-100452820",false,"NCT05176483","Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors","A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology or Other Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors","STELLAR-002","Key Inclusion Criteria:\n\n* Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.\n* Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n* Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.\n\n  * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.\n* Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.\n\n  * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)\u002FProgrammed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.\n  * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.\n* Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.\n\n  * Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.\n* Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).\n\n  * Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence \\\u003C 12 months from the end of last therapy.\n  * Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.\n* Expansion Cohort 5 (post enfortumab vedotin \\[EV\\] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.\n\n  * Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1\u002FPD-L1 inhibitor or ineligible for PD-1\u002FPD-L1 inhibitor.\n  * Prior receipt of platinum-based therapy allowed but not required.\n  * Prior therapy with other agents allowed but not required.\n* Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.\n\n  * No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.\n* Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and\u002For unresectable HCC that is not amenable to curative treatment or locoregional therapy.\n* Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score \\[TPS\\] 1-49%) and without prior systemic anticancer therapy for metastatic disease.\n* Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.\n* Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.\n* Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.\n* Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.\n\n  * Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma\n* Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.\n* Cohort 15 (mCRPC, post-ARPI, visceral metastases): Men with metastatic adenocarcinoma of the prostate.\n* Cohort 16 (Drug-drug interaction \\[DDI\\]):\n\n  * Participants with a solid tumor that is unresectable or metastatic and for which life prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n  * Able to swallow capsules or tablets.\n* For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.\n* For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.\n* Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and\u002For stable on supportive therapy.\n* Karnofsky Performance Status (KPS) ≥ 70%.\n* Adequate organ and marrow function.\n* Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.\n* Females of childbearing potential must not be pregnant at screening.\n\nKey Exclusion Criteria:\n\n* For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1\u002FPD-L1, Lymphocyte-activation gene 3 (LAG-3) and cytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n* Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.\n* Administration of a live, attenuated vaccine within 30 days prior to first dose.\n* Uncontrolled, significant intercurrent or recent illness.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 460 ms for females and \\> 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.\n* Participants with inadequately treated adrenal insufficiency.\n* Pregnant or lactating females.\n* Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.\n* For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.\n* For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.\n* For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.\n* For Cohort 7 (HCC):\n\n  * Documented hepatic encephalopathy (HE) within 6 months before the first dose.\n  * Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.\n  * Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.\n  * Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma\n* For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and\u002For trifluridine + tipiracil (TAS-102).\n* For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.\n* For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable \\[MSS\\], 2L+), and 11 (HNSCC):\n\n  * Troponin T (TnT) or I (TnI) \\> 2 × institutional upper limit of normal (ULN).\n* For Cohort 16 (DDI):\n\n  * Known hypersensitivity to midazolam, warfarin, omeprazole, or caffeine.\n  * History of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within 3 months prior to first dose of study treatment on Day 1.\n  * Primary liver tumor.\n  * Unable to refrain from or anticipates the use of the following:\n\n    * Any drugs known to be inducers or inhibitors of CYP3A4, CYP2C9, CYP2C19, and\u002For CYP1A2 within 14 days before the first dose of study treatment on Day 1 through the DDI assessments on Day 20.\n    * Drugs that are contraindicated with midazolam, warfarin, omeprazole, and\u002For caffeine during the DDI assessment part.\n    * Caffeine-containing beverages, products, and foods at least 3 days prior to and 3 days after probe substrate cocktail administration on Day 1 and Day 16.\n\n      * Poor peripheral venous access.\n\nNote: Additional Inclusion and Exclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},1394,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) and in combination with docetaxel and prednisone in participants with advanced solid tumors. In addition, the study will evaluate the effect of multiple dose administration of zanzalintinib on the single-dose pharmacokinetics of sensitive CYP3A4, CYP2C9, CYP2C19, or CYP1A2 substrates in participants with advanced solid tumors.\n\nIn the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.",[27,28,29,30,31,32,33,34,35,36,37],"Renal Cell Carcinoma (RCC)","Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Urothelial Carcinoma (UC)","Solid Tumor","Hepatocellular Carcinoma (HCC)","Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)","Drug-Drug Interaction (DDI)","RECRUITING","2026-08-03",{"date":41,"type":42},"2026-08-05","ACTUAL",{"date":44,"type":42},"2021-12-14",{"date":46,"type":21},"2030-06-28",{"name":48,"class":49},"Exelixis","INDUSTRY",122,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100650236","phase-1-a-drug-drug-interaction-study-between-ntq5082-capsules-and-midazolam-oral-solutio-100650236","NCT07745439","A Drug-Drug Interaction Study Between NTQ5082 Capsules and Midazolam Oral Solutio","Inclusion Criteria:\n\n1. Healthy male or female participants aged 18 to 45 years, inclusive.\n2. Body mass index (BMI) from 19.0 to 26.0 kg\u002Fm², inclusive, with a body weight of at least 50 kg for males and at least 45 kg for females.\n3. Participants who voluntarily sign the informed consent form before any study-related procedure and fully understand the study content, procedures, and potential adverse reactions.\n4. Participants who are able to communicate effectively with the investigator and understand and comply with all study requirements.\n5. Participants who are willing to receive an ACYW135 meningococcal vaccine and a pneumococcal vaccine at least 14 days before the first dose. Repeat vaccination is not required if the participant received a pneumococcal vaccine within 5 years before dosing or an ACYW135 meningococcal vaccine within 3 years before dosing.\n\nExclusion Criteria:\n\n1. Participation in any other drug clinical trial and receipt of an investigational medicinal product within 3 months before admission to the clinical research unit.\n2. A history of chronic or active gastrointestinal disease within 3 years before admission, including esophageal disease, gastritis, gastric ulcer, gastroesophageal reflux disease, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery, that is considered clinically significant by the investigator.\n3. A confirmed disease of the central nervous, cardiovascular, gastrointestinal, respiratory, endocrine, urinary, hematologic and lymphatic, or metabolic system requiring medical intervention, or any other condition, including a psychiatric history, that may make the participant unsuitable for the study.\n4. A known or suspected history of immunodeficiency, such as frequent recurrent infections, or a history of hereditary or acquired complement deficiency.\n5. A confirmed history of infection caused by encapsulated microorganisms within 6 months before admission, including but not limited to Streptococcus pneumoniae, Bacillus anthracis, Salmonella species, Salmonella Typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae, or Legionella pneumophila.\n6. A history of tuberculosis infection or current tuberculosis infection.\n7. An active systemic bacterial, viral, or fungal infection within 14 days before the first dose.\n8. Symptoms such as dizziness, headache, abdominal pain, diarrhea, or constipation within 14 days before the first dose that, in the investigator's opinion, make the participant unsuitable for the study.\n9. Known hypersensitivity to either study intervention, any of their components, or related preparations, or a history of allergy to drugs, food, or other substances.\n10. Inability to tolerate venipuncture or a history of fainting in response to blood or needles.\n11. Surgery within 6 months before admission that, in the investigator's opinion, may affect drug absorption, distribution, metabolism, or excretion; any surgical procedure within 30 days before admission; or planned surgery during the study.\n12. Use of any medication within 28 days before admission, including prescription drugs, nonprescription drugs, traditional Chinese medicines, Chinese patent medicines, or dietary supplements, or use within 5 half-lives of the medication at screening, whichever period is longer.\n13. Receipt of any vaccine, including a live attenuated vaccine, within 14 days before the first dose, except for the meningococcal and pneumococcal vaccines required by the protocol, or planned vaccination during the study.\n14. Corrected QT interval (QTc) of at least 450 milliseconds for males or at least 460 milliseconds for females at screening.\n15. Blood donation or significant blood loss of more than 400 mL, blood transfusion, or receipt of blood products within 3 months before admission, or an intention to donate blood or blood components during the study or within 3 months after study completion.\n16. A history of drug abuse or use of soft drugs, such as marijuana, or hard drugs, such as cocaine or phencyclidine, within 1 year before admission.\n17. Regular smoking or smoking more than 5 cigarettes per day within 3 months before admission, or inability to discontinue all tobacco products during the study.\n18. Alcohol abuse or regular alcohol consumption within 6 months before admission, defined as more than 14 units of alcohol per week, where 1 unit is equivalent to 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine, or unwillingness to abstain from alcohol and alcohol-containing products during the study.\n19. Consumption of excessive amounts of tea, coffee, or other caffeinated beverages, defined as more than 8 cups per day, with 1 cup equal to 250 mL, or unwillingness to discontinue such beverages during the study.\n20. Consumption within 7 days before admission of grapefruit, grapefruit-containing products, or other foods that may affect drug absorption, distribution, metabolism, or excretion, or unwillingness to avoid such foods during the study.\n21. Special dietary requirements or inability to comply with the standardized diet provided during the study.\n22. Female participants who are pregnant or breastfeeding; who have had unprotected sexual intercourse within 14 days before admission; who have used oral contraceptives within 30 days before admission; or who have used long-acting estrogen or progestogen injections or implants within 6 months before admission.\n23. Participants, or their partners, who plan pregnancy or sperm or oocyte donation from the time of signing informed consent through 3 months after the last dose, or who are unwilling to use at least one nonpharmacologic contraceptive method, such as complete abstinence, an intrauterine device, or partner sterilization.\n24. Clinically significant abnormalities, as determined by the investigator, in physical examination, electrocardiogram, abdominal ultrasound, chest radiograph, vital signs, or laboratory examinations, including hematology, urinalysis, blood chemistry, procalcitonin, coagulation, thyroid function, infectious disease screening, or serum pregnancy testing for females.\n25. A positive alcohol breath test or drug abuse screening result.\n26. Any other condition that, in the investigator's opinion, may prevent the participant from completing the study or otherwise make the participant unsuitable for participation.",true,"45 Years",{"count":60,"type":21},18,[24],"This is a single-center, non-randomized, open-label, single-sequence, self-controlled drug-drug interaction study in healthy participants.\n\nThe main purpose of the study is to evaluate whether a single dose and repeated daily doses of NTQ5082 capsules affect the pharmacokinetics of midazolam oral solution. Midazolam is used in this study as a probe drug to assess the activity of cytochrome P450 3A (CYP3A), an enzyme involved in the metabolism of many medicines.\n\nApproximately 18 healthy male and female participants will be enrolled. Participants will receive a single oral dose of midazolam 2 mg on Days 1, 4, and 11. NTQ5082 200 mg will be administered orally once daily from Day 4 through Day 12. Blood samples will be collected to measure the concentrations of midazolam and its metabolite, 1'-hydroxymidazolam, and to calculate pharmacokinetic parameters.\n\nThe safety and tolerability of midazolam administered alone and together with NTQ5082 will also be evaluated through adverse event monitoring, laboratory tests, vital signs, physical examinations, and electrocardiograms. The study includes a screening and protocol-required vaccination period, an inpatient treatment period, and a safety follow-up telephone call within 7 days after discharge.",[64,37],"Healthy Volunteers",[66,67,68,69,70,71,72,64],"NTQ5082","Midazolam","CYP3A","Drug-Drug Interaction","Pharmacokinetics","Pharmacokinetic Interaction","Complement Factor B Inhibitor","NOT_YET_RECRUITING","2026-07-29",{"date":76,"type":42},"2026-08-04",{"date":78,"type":21},"2026-07-30",{"date":80,"type":21},"2027-07-31",{"name":82,"class":83},"The Third Xiangya Hospital of Central South University","OTHER",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100572469","phase-1-safety-and-pk-of-ceftibuten-ledaborbactam-etzadroxil-fixed-dose-combination-100572469","NCT06733675","Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination","A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil","Inclusion Criteria:\n\n* Healthy adult male or female, between 18 and 55 years of age\n* Body mass index ≥ 18 and ≤ 32 kg\u002Fm2\n* Laboratory values meeting defined laboratory ranges\n* Males or non-pregnant, non-lactating females\n\nExclusion Criteria:\n\n* History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug\n* Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant\n* Positive alcohol, drug or tobacco use\u002Ftest","55 Years",{"count":93,"type":21},96,[24],"This is a Phase 1, open-label, three-part, study in approximately 96 healthy adult participants between 18 and 55 years of age (both inclusive) (16 participants in Part 1, 20 participants in Part 2 and , and approximately 60 participants in Part 3). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 , 43 days for Part 2 and 83 days for Part 3. All participants in Parts I und 2 will be screened within 28 days prior to dosing. All participants in Part 3 will be screened within 33 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention. Participants in Part 3 will also return to the clinic for follow-up assessments 28 days ± 2 days and 42 days ± 2 days after the last dose of study intervention.",[97,70,98,37,99],"Healthy Volunteer","Safety","FDC",[64,101,102],"Ceftibuten","Ledaborbactam etzadroxil","2026-07-07",{"date":105,"type":42},"2026-07-09",{"date":107,"type":42},"2025-01-07",{"date":109,"type":21},"2026-12-30",{"name":111,"class":49},"Basilea Pharmaceutica",1,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":112},"100628097","phase-1-study-on-the-drug-interaction-between-buagafuran-and-voriconazole-100628097","NCT07457203","Study on the Drug Interaction Between Buagafuran and Voriconazole","Clinical Study on the Drug Interaction Between Buagafuran Capsules and Voriconazole Tablets in Chinese Adult Healthy Participants","Inclusion Criteria:\n\n1. Voluntarily sign an informed consent form before the start of activities related to this experiment and be able to understand the procedures of this experiment Willing to strictly adhere to the clinical trial protocol and complete this trial in accordance with the method;\n2. Participants (including partners) are willing to have no fertility plans from screening to within 6 months after the last administration of the investigational drug, and voluntarily adopt highly effective contraceptive measures (specific contraceptive measures can be found in Appendix 1);\n3. On the day of signing the informed consent form, the age range is 18 to 45 years old (including both ends), and both males and females are eligible;\n4. Male participants weighing no less than 50 kg and female participants weighing no less than 45 kg; Body Mass Index (BMI)19-28 kg\u002Fm2 (including both ends), body mass index (BMI)=weight (kg)\u002Fheight 2 (m2);\n5. Creatinine clearance rate (calculated using the Cockcroft Gault formula, see Appendix 2) ≥ 80 mL\u002Fmin.\n\nExclusion Criteria:\n\n1. Screening period physical examination, vital sign examination, 12 lead electrocardiogram, clinical laboratory examination (blood routine Abnormal and clinically significant factors such as blood biochemistry, urine routine, coagulation function, etc. have been identified by researchers;\n2. Clinical findings indicate the presence of the following diseases: including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, and endocrine disorders Secretory, tumor, lung, immune, psychiatric or cardiovascular diseases that the researcher deems unsuitable to participate in this study Researcher;\n3. Any potential impact on the safety of the trial or drug absorption, distribution, metabolism, or excretion within the first 6 months of screening Individuals with a history of surgery or trauma, or those planning to undergo surgery during the study period;\n4. History of swallowing difficulties or any gastrointestinal diseases that affect drug absorption, including frequent malignant events caused by any underlying cause Individuals with a history of heart or vomiting;\n5. Individuals with a history of eye diseases (such as retinal hemorrhage, optic nerve abnormalities, etc.);\n6. Individuals with previous risk factors for arrhythmia, such as congenital or acquired QTc interval prolongation, cardiomyopathy, and menstrual disorders Researchers have identified clinically significant abnormalities such as sinus bradycardia;\n7. Participate in blood donation within 3 months prior to screening and donate ≥ 400 mL (excluding female menstrual bleeding), or Blood transfusion recipients;\n8. Screening for use of other clinical trial drugs within the first 3 months or planned participation in other clinical trials during the study period The person;\n9. Individuals with a history of drug abuse, drug dependence, drug use, or urinary drug abuse within the past 5 years prior to screening Individuals with positive screening results;\n10. Individuals with a history of alcohol abuse or those who have frequently consumed alcohol within the past 6 months, i.e. those who consume ≥ 14 units of alcohol per week (1 Unit=360 mL of beer with an alcohol content of 5%, 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of alcohol 12% wine), or any alcoholic product taken on the day before the first dose, or alcohol blowing Individuals who test positive for alcohol or are unable to stop consuming alcohol during the study period;\n11. Excessive smoking (≥ 5 cigarettes\u002Fday) within the first 3 months of screening, or inability to stop smoking during the trial period;\n12. Those who are positive in any index screening of hepatitis B surface antigen, hepatitis C antibody, HIV antigen\u002Fantibody or syphilis antibody;\n13. Used any drugs that affect liver enzymes within the previous month (or 5 times half-life, whichever is longer) before screening Active drugs (including inhibitors and inducers that affect metabolic enzymes);\n14. Within 14 days prior to the first use of the investigational drug, any prescription, over-the-counter, herbal, or herbal medicine has been used Health products (excluding topical preparations that exert local effects);\n15. Consuming grapefruit or products containing grapefruit, caffeine, and yellow within 48 hours prior to taking the investigational drug Foods or beverages containing purines or alcohol (including chocolate, tea, coffee, cola, etc.); Intense exercise, or Those who have other factors that affect drug absorption, distribution, metabolism, excretion, etc;\n16. Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection;\n17. Allergic constitution, including severe drug allergies or a history of drug allergies, known to be sensitive to experimental drugs or drugs Individuals allergic to any ingredient in the medication;\n18. From the screening stage to the occurrence of acute illness or concomitant medication before the study drug;\n19. Pregnant or lactating women, or women of childbearing age who test positive for pregnancy;\n20. Researchers believe that there are other factors that are not suitable for participating in this experiment.",{"count":60,"type":21},[24],"This study is a non-randomized, open label trial aimed at evaluating the drug interaction between Buagafuran capsules and voriconazole tablets in Chinese adult healthy participants.The research period is 7 days in total.",[124],"Drug Drug Interaction (DDI)","2026-03-03",{"date":127,"type":42},"2026-03-09",{"date":129,"type":21},"2026-04",{"date":131,"type":21},"2026-05",{"name":133,"class":49},"Beijing Union Pharmaceutical Factory Ltd",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":57,"sex":17,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":112},"100613352","phase-1-to-evaluate-the-safety-and-the-pharmacokinetic-and-pharmacodynamic-interactions-between-jp-1366-and-clopidogrel-aspirin-atorvastatin-and-apixaban-100613352","NCT07265466","to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban","A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban in Healthy Volunteers.","Inclusion Criteria:\n\n* Healthy subject aged ≥ 19 years to \\\u003C 65 years at the time of screening\n* Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg\u002Fm2 and ≤ 30.0 kg\u002Fm2\n* Subjects who have voluntarily decided to participate after fully understanding the clinical trial based on the detailed explanation given, and have provided written informed consent before the screening procedure.\n\nExclusion Criteria:\n\n* Subject who has a clinically significant history of disease in the liver, kidneys, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hematopoietic and oncological system, or cardiovascular system.\n* The Subject who has a clinically significant bleeding or a history of congenital or acquired bleeding disorders such as hemophilia\n* Subject who has a history of gastrointestinal disorders (e.g., Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia repair, endoscopic polypectomy, or hemorrhoidectomy, fissure, or fistula surgery) that may affect the absorption of the investigational product.\n* The subject who has a hereditary disorder (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.).\n* Screening laboratory test showing any of the following abnormal laboratory results\n* Subjects who are judged unsuitable to participate in the study in the opinion of the investigator","19 Years","64 Years",{"count":93,"type":21},[24],"to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban",[124],"2025-12-02",{"date":149,"type":42},"2025-12-04",{"date":151,"type":42},"2025-11-17",{"date":153,"type":21},"2026-03-30",{"name":155,"class":49},"Onconic Therapeutics Inc."]