[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490863":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":25,"locations":36,"responsibleParty":50,"collaborators":25,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":25,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":25,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":73,"whyStopped":74,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: PF-07081532","EXPERIMENTAL","Cohort 1 is an open-label, 9 period, fixed-sequence design to evaluate the effect of 2 steady state dose levels of PF-07081532 on the SD pharmacokinetics of midazolam and omeprazole, administered simultaneously, and an OC (LE\u002FEE) in otherwise healthy obese adult female participants with a BMI ≥30 kg\u002Fm2.",[13],"Drug: PF-07081532",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: Semaglutide","Cohort 2 is an open label, 4-period, fixed-sequence design to evaluate the effect of steady state semaglutide on the SD PK of midazolam in obese adult female participants with a BMI ≥30 kg\u002Fm2",[18],"Drug: Semaglutide",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","PF-07081532","Experimental oral GLP-1 drug",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Semaglutide","Approved and marketed GLP-1 drug for subcutaneous injection.",[15],[31],"Wegovy, Ozempic",[33],{"name":34,"affiliation":5,"role":35},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":25},"Anaheim Clinical Trials, LLC","Anaheim","California","92801","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-117.9145,33.83529,{"lat":48,"lon":47},{"type":51,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100490863","phase-1-a-study-to-evaluate-the-effect-of-the-experimental-glp-1-drug-pf-07081532-on-blood-levels-of-common-birth-control-pills-and-drugs-omeprazole-and-midazolam-and-effect-of-glp-1-drug-semaglutide-on-midazolam-blood-levels-in-healthy-adults-with-weight-in-the-obesity-range-100490863",true,"NCT05671653","A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range","A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY-STATE DOSE LEVELS OF PF-07081532 ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, OMEPRAZOLE AND AN ORAL CONTRACEPTIVE, AND THE EFFECT OF STEADY-STATE SEMAGLUTIDE ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, IN OBESE ADULT FEMALE PARTICIPANTS","Inclusion Criteria:\n\n* Healthy (no clinically relevant abnormalities)\n* BMI 30.0-45.4 inclusive\n\nExclusion Criteria:\n\n* Current or history of significant clinical condition\n* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 or 14 days or 5 half-lives (whichever is longer)\n* Pregnant\n* Breast feeding","FEMALE","18 Years",{"count":62,"type":63},32,"ACTUAL","INTERVENTIONAL",[66],"PHASE1","Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide. The effect of these GLP-1 drugs on a single dose of the common sedative medication midazolam blood levels will be measured. The effect of chronic PF-07081532 on single doses of the common stomach acid medication omeprazole, and common birth control medication blood levels will also be measured. The hypothesis is that chronic administration of the GLP-1 drugs will minimally affect blood levels from these common medications.",[69],"Obesity",[71,72,22],"Midazolam","Omeprazole","TERMINATED","The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.","2025-01-06",{"date":77,"type":63},"2025-01-14",{"date":79,"type":63},"2023-01-19",{"date":81,"type":63},"2023-11-03",{"name":5,"class":6},1]