[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pharmacokinetics-after-oral-intake\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pharmacokinetics-after-oral-intake":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100650369","rosuvastatin-and-losartan-pharmacokinetics-after-bariatric-surgery-100650369",false,"NCT07748273","Rosuvastatin and Losartan Pharmacokinetics After Bariatric Surgery","Comparative Evaluation of Rosuvastatin and Losartan Pharmacokinetics and the Associations Between Gut Microbiota Alterations and Changes in Systemic Drug Exposure in Patients Undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy","BARI-PK","Inclusion Criteria:\n\n* Adults aged 18 to 65 years;\n* Formal clinical indication for RYGB or sleeve gastrectomy after multidisciplinary assessment;\n* Bariatric surgery scheduled and no previous bariatric procedure;\n* Able to understand the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Moderate or severe hepatic impairment, liver enzymes greater than 3 times the upper limit of normal, or Child-Pugh class B or C.\n* Estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m².\n* Concomitant use of drugs that substantially affect rosuvastatin pharmacokinetics and cannot be temporarily discontinued, including cyclosporine, gemfibrozil, or potent OATP1B1\u002FBCRP or CYP2C9 inhibitors.\n* Systemic antibiotic use within 3 months or probiotic, prebiotic, or synbiotic use within 4 weeks before sampling.\n* Continuous current rosuvastatin or other statin therapy unless medically discontinued with an adequate washout period under physician supervision.\n* Clinically relevant baseline hypotension, significant hyperkalemia, renal impairment, or another condition that makes a losartan test dose unsafe.\n* Severe postoperative complication preventing oral dosing, including active gastrointestinal leak, intractable vomiting, or severe anastomotic stenosis.\n* Pregnancy. Participants of childbearing potential undergo routine preoperative beta-hCG testing.","ALL","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","This prospective, open-label, non-randomized pharmacokinetic study will evaluate how Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy affect systemic exposure to single oral test doses of rosuvastatin and losartan. Sixty adults scheduled for bariatric surgery will enter one of two parallel groups according to the clinically selected operation (30 RYGB and 30 sleeve gastrectomy). Each participant will receive rosuvastatin 10 mg and losartan 25 mg once within 30 days before surgery and again approximately 12 weeks after surgery. Plasma samples collected before dosing and at 1.5 and 4 hours after dosing will be used with maximum a posteriori Bayesian estimation to estimate individual pharmacokinetic parameters. In the 30-participant RYGB group only, paired stool samples will be used to explore gut microbiota and untargeted fecal metabolomic changes. The primary objective is to compare within-participant changes and between-procedure differences in drug exposure after bariatric surgery.",[28,29,30,31],"Obesity & Overweight","Bariatric Surgery","Pharmacokinetics After Oral Intake","Drug Absorption",[33,34,35,36,37,38,39,40],"Roux-en-Y gastric bypass","sleeve gastrectomy","rosuvastatin","losartan","E-3174","gut microbiota","metabolomics","systemic exposure","NOT_YET_RECRUITING","2026-08-03",{"date":44,"type":45},"2026-08-05","ACTUAL",{"date":47,"type":22},"2026-08-02",{"date":49,"type":22},"2027-05-15",{"name":51,"class":52},"Hospital das Clínicas de Ribeirão Preto","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":53},"100600078","phase-1-pharmacokinetics-of-sulopenem-etzadroxil-plus-probenecid-in-adolescents-100600078","NCT07092813","Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents","A Phase 1, Multi-Center, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Sulopenem Etzadroxil + Probenecid in Adolescent Patients With Bacterial Infection","Inclusion Criteria:\n\n1. Patient's parent\u002Fboth parents or guardian must provide written informed consent and a statement of assent from the adolescent patient (if required by Institutional Review Board \\[IRB\\] according to local regulations and guidelines) must be obtained prior to any study-related procedures. Communication should take place between the Investigator, parent(s)\u002Fguardian, and adolescent patient to confirm understanding and compliance with the study requirements.\n2. Patient is male or female adolescent who are more than or equal to 12 and \\\u003C18 years of age.\n3. Patient has a diagnosis of a bacterial infection as documented by the treating physician\n4. Patient will be receiving appropriate anti-infective treatment for a bacterial infection.\n5. Patient must have sufficient venous access to permit collection of PK samples and monitoring of laboratory safety variables.\n6. Female patients who are postmenarchal must not be pregnant, or breast feeding and must have a documented negative pregnancy test at Screening.\n7. Postmenarchal females and post-pubertal males must agree to use a highly effective method of birth control with partners of childbearing potential throughout the duration of the study and for 1 month following the last dose of study drug.\n\n   NOTE: A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \\\u003C1% per year) when used consistently and correctly. This includes sexual abstinence, implants, some intrauterine devices, or a vasectomized partner. A vasectomy or a condom used with a spermicide is a medically acceptable form of birth control for males.\n8. Patient must be willing to follow all study procedures.\n\nExclusion Criteria:\n\n1. Known renal insufficiency.\n2. Patient is unable to tolerate oral medications.\n3. Patient has presence of any of the following conditions:\n\n   1. Endocarditis\n   2. Meningitis\n   3. Necrotizing fasciitis\n   4. Gas gangrene\n4. Patient has signs of severe sepsis including:\n\n   1. Shock or profound hypotension that is not responsive to fluid challenge.\n   2. Disseminated intravascular coagulation as evidenced by prothrombin time or partial thromboplastin time more than or equal to 2 × the upper limit of normal (ULN) or platelets \\\u003C50% of the lower limit of the normal.\n5. Patient has known active liver disease or hepatic dysfunction (except a confirmed diagnosis of Gilbert's disease) defined as non-transient elevations of aspartate aminotransferase or alanine aminotransferase level elevations more than or equal to 3 × the ULN or non-transient total bilirubin more than or equal to 2 × the ULN.\n6. Known neutropenia (absolute neutrophil count \\\u003C500 cells\u002Fmm3).\n7. Patient has history of solid organ transplantation reported at any time.\n8. Patient has any finding that, in the view of the Investigator, would compromise the patient's safety requirements.\n9. Patient has known allergies to penicillin, carbapenems, and\u002For cephalosporin antibiotics, known allergy to probenecid, or severe allergic reactions to any drug in the past.\n10. Patient has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.\n11. Patient or parent\u002Flegal guardian has involvement in the planning and\u002For conduct of this study (applies to both Iterum Therapeutics staff and\u002For staff at the study sites).\n12. Patient has participated in any other clinical study where an investigational product was ingested within 30 days or 5 half-lives of the drug (whichever is longer) prior to the current study.\n13. Patient has definite or suspected personal history or family history of clinically significant adverse drug reactions.\n14. Patient has history or presence of GI, hepatic, or renal disease, or other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n15. Patient had treatment in the previous 3 months with any drug known to have a well-defined potential for hepatotoxicity (e.g., halothane).\n16. Patient weighs \\\u003C30 kg.\n17. Patient is pregnant or lactating.\n18. Patient has received a carbapenem as their standard of care therapy to treat the diagnosed bacterial infection.","12 Years","17 Years",{"count":64,"type":22},12,[66],"PHASE1","The goal of this clinical trial is to evaluate the use of sulopenem etzadroxil plus probenecid in adolescent patients being treated for bacterial infection. The main questions it aims to answer are:\n\nIs sulopenem etzadroxil plus probenecid safe to use in adolescents? Is sulopenem etzadroxil plus probenecid tolerable when used in adolescents? When ingested, what does the adolescent body do to sulopenem etzadroxil plus probenecid, in terms of the movement of the drug into, through, and out of the body.\n\nParticipants will receive standard of care antibiotics for their bacterial infection as directed by their physician. In addition, participants will be asked to take a single oral dose of sulopenem etzadroxil plus probenecid. Blood samples will be collected before the dose of sulopenem etzadroxil plus probenecid, as well as at specified timepoints after the dose. Likewise, urine will be collected at specified time periods after the dose. During the course of the study, data will be collected from participants including vital sign measurements, physical examination findings, and the details of any adverse events that are reported.",[30],[70,71,72,73,74,75],"Pharmacokinetics","Adolescents","Sulopenem etzadroxil","Probenecid","Sulopenem","Phase 1","RECRUITING","2026-03-23",{"date":79,"type":45},"2026-03-27",{"date":81,"type":22},"2026-04",{"date":83,"type":22},"2026-10",{"name":85,"class":86},"Iterum Therapeutics, International Limited","INDUSTRY"]