[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pharmacodynamics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pharmacodynamics":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100581237","phase-1-single-ascending-dose-and-multiple-ascending-dose-study-of-avr-48-100581237",false,"NCT06847698","Single Ascending Dose and Multiple Ascending Dose Study of AVR-48","Phase 1, Double-Blinded, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Safety and Pharmacokinetics Trial of AVR-48","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form (ICF).\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Healthy adult male or female, aged 18 to 55, inclusive, at Screening.\n4. Continuous non smoker who has not used nicotine containing products (including e- vaping) for at least 3 months prior to the first dosing and throughout the study\n5. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg\u002Fm2 at screening, and a minimum weight of at least 50.0 kg and a maximum weight of 100.0 kg at screening.\n6. Medically healthy with no clinically significant abnormalities in medical history, physical and neurologic examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.\n7. If female of childbearing potential, must be consistently using an effective method of contraception from screening visit until 30 days after the last drug administration.\n8. If female and not of childbearing potential, must be either surgically sterile or post menopausal (i.e., more than 1 year since last menstrual period).\n9. A non-vasectomized, male subject must agree to use an effective method of birth control with female partners of childbearing potential during the study and to refrain from donating sperm for 90 days following dosing.\n10. No restrictions are required for a vasectomized male subject provided his vasectomy has been performed 4 months or more (and have official documentation) prior to Study Day 1. A subject who has been vasectomized less than 4 months prior to Study Day 1 or does not have official documentation of his vasectomy must follow the same restrictions as a non-vasectomized subject.\n\nExclusion Criteria:\n\n1. Are mentally or legally incapacitated or have significant emotional problems at the time of the screening visit or expected during the conduct of the study in the opinion of the PI or designee.\n2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.\n4. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.\n5. Has had surgery or any medical condition within 6 months prior to first dosing which may affect the distribution, metabolism, or elimination of the study drug, in the opinion of the PI or designee.\n6. Female subjects with a positive pregnancy test or who are lactating.\n7. Positive urine drug or alcohol results at screening or first check-in.\n8. Positive cotinine results at screening.\n9. Positive result at screening for tuberculosis (i.e., positive result for QuantiFERON TB-Gold).\n10. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).\n11. Unable to refrain from or anticipates the use of:\n\n    • Any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing and throughout the study. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee. Hormone replacement therapy will be allowed.\n12. Donation or loss of 50 to 499 mL whole blood within 30 days or more than 499 mL whole blood within 56 days prior to the first dosing.\n13. Plasma donation within 14 days prior to the first dosing.\n14. Participation in another clinical study within 30 days prior to the first dosing. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.\n15. Had a treatment with other investigational drug within 5 times the terminal elimination half-life (t1\u002F2), if known (e.g., a marketed product) or within 30 days (if the t1\u002F2 is unknown), whichever is longer, prior to Study Day 1 dosing.\n16. Evidence of Coronavirus Disease 2019 (COVID-19) infection.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). SAD will be initiated first and include a sentinel dosing design. MAD will not utilize a sentinel design unless the safety monitoring committee requests the addition of sentinels. The MAD will be initiated once the lowest doses from SAD are deemed safe.",[28,29,30,31],"Safety Issues","Tolerability","Pharmacokinetics","Pharmacodynamics","NOT_YET_RECRUITING","2025-04-03",{"date":35,"type":36},"2025-04-06","ACTUAL",{"date":38,"type":22},"2025-06",{"date":40,"type":22},"2025-11",{"name":42,"class":43},"AyuVis Research, Inc.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":44},"100552158","phase-1-kf20231-trial-influence-of-statin-intake-on-cellular-readouts-100552158","NCT06469450","KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts","Inclusion Criteria:\n\n1. a signed written informed consent\n2. age 18-40 years\n3. healthy, and\n4. Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.\n5. Fully vaccinated against COVID-19.\n\nExclusion Criteria:\n\n1. significant disease\n2. smoking\n3. SLCO1B1 poor function genotype\n4. oral contraception or other continuous medication\n5. pregnancy, planning of pregnancy or breastfeeding\n6. participating in a clinical trial less than 3 months ago\n7. donating blood less than 3 months ago\n8. marked obesity\n9. anticipated difficulties in drawing blood samples\n10. weight less than 45 kg\n11. BMI less than 18.5 kg\u002Fm2 or\n12. inadequate Finnish language skills","40 Years",{"count":53,"type":22},15,[25],"A majority of high-risk patients does not achieve their cholesterol target levels and most of these patients do not receive more effective combination therapy, which goes beyond statin monotherapy. Large interindividual differences in treatment outcomes have been observed for patients receiving statins. Statins block cholesterol synthesis and increase cellular low-density lipoprotein (LDL) uptake. Importantly, LDL uptake is highly divergent in individuals.The aim of this trial is to investigate how atorvastatin influences leukocyte readouts of LDL uptake and lipid storage in humans. The trial is a single-arm, open-label, interventional trial. A total of 15 healthy volunteers will receive 40 mg atorvastatin once a day for 4 weeks. The participants will provide blood samples before starting the atorvastatin intervention, each week when taking atorvastatin, and one week after the end of the intervention for the measurement of leukocyte readouts of LDL uptake and lipid storage.",[31],"RECRUITING","2024-06-17",{"date":60,"type":36},"2024-06-21",{"date":62,"type":36},"2024-04-20",{"date":64,"type":22},"2024-12-31",{"name":66,"class":67},"Mikko Niemi","OTHER",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100497984","imapct-of-biomarkers-on-pharmacodynamics-and-bleeding-risk-of-direct-oral-anticoagulants-and-ticagrelor-study-ii-100497984","NCT05764356","Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II","Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II (IMPACT 2)","Inclusion Criteria:\n\n(I) Chinese Patients taking NOACs\n\n* In accordance with anticoagulation indications of NOACs, include prevention of thrombosis in non valvular atrial fibrillation, prevention and treatment of deep vein thrombosis \u002F pulmonary embolism and prevention of thrombosis after knee \u002F hip replacement;\n* More than 18 years of age, male or female;\n* Never received NOACs in a month and intend to take NOACs or have received NOACs for more than one week continuously;\n* sign informed consent.\n\n(II) Chinese Patients taking ticagrelor\n\n* With diagnosis of acute coronary syndrome (ACS), included unstable angina, non ST segment elevation myocardial infarction and ST segment elevation myocardial infarction;\n* More than 18 years of age, male or female;\n* Never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously#\n* sign informed consent.\n\nExclusion Criteria:\n\n* With history of immunodeficiency disease, including positive HIV index;\n* Positive Hepatitis B surface antigen (HBsAg) and HCV index;\n* Combined therapy of CYP3A4 strong inhibitors and P-gp inhibitors (e.g., systemic pyrrole antifungal agents such as ketoconazole, itraconazole, voriconazole and posaconazole; human immunodeficiency virus (HIV) - protease inhibitors such as ritonavir), CYP3A4 strong inducers and P-gp inducers (e.g., rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort, etc.) in 14 days before treatment with NOACs;\n* Severe liver dysfunction and abnormal renal function;\n* Include contraindications of antithrombosis, such as hypersensitivity, active bleeding, moderate or severe liver disease, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days.",{"count":76,"type":22},2000,"OBSERVATIONAL","Individual differences in drug efficacy and adverse reactions are common in the clinical application of drugs. Individual differences are caused by many factors, among which genetic factors account for more than 20%. Novel oral anticoagulant drugs (NOACs, including rivaroxaban, apixaban, edoxaban, dabigatran, etc.) and novel antiplatelet drug ticagrelor have the advantages of convenient use and no need for monitoring. But novel oral antithrombotic drugs also increase the risk of bleeding, and there is currently a lack of effective antagonists when antithrombosis is excessive or emergency surgery is required. At present, there are few studies on the causes of individual differences in novel antithrombotic drugs, and there is a lack of predictable biomarkers or drug genotypes, especially in China. Therefore, on the basis of previous studies on NOACs and ticagrelor individualized medication cohorts, this study plans to establish a validation cohort for novel antithrombotic drugs bleeding related biomarkers, conduct multi-omics testing and long-term follow-up, and explore markers related to pharmacodynamics of antithrombotic drugs, adverse bleeding reactions and clinical outcomes.",[80,81,82,83,84,85,86,31,87,88,89,90],"Novel Oral Anticoagulants","NOACs","Rivaroxaban","Apixaban","Edoxaban","Dabigatran","Ticagrelor","Pharmacogenomics","RNA Profile","Bleeding","Biomarker","2023-03-01",{"date":93,"type":36},"2023-03-10",{"date":95,"type":22},"2023-03",{"date":97,"type":22},"2027-12",{"name":99,"class":67},"Peking University First Hospital",6]