[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100352095":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":40,"locations":41,"responsibleParty":55,"collaborators":40,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":40,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":40,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":83,"whyStopped":40,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pharmacokinetic study in healthy volunteers","EXPERIMENTAL","Healthy participants received a single dose of rivaroxaban 10 mg orally on day 1 (phase 1) followed by cobicistat 150 mg once daily from days 2 - 7 and a single dose of rivaroxaban 10 mg on day 7 (phase 2). Participants received darunavir \u002Fcobicistat 800\u002F150 mg once daily from days 8 - 13 followed by a single dose of rivaroxaban 10mg on day 13 (phase 3). Serial blood sampling was done on days 1, 7, and 13.",[13,14,15],"Drug: Cobicistat","Drug: Darunavir\u002FCobicistat","Drug: Rivaroxaban",[17,24,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Cobicistat","Each tablet of Tybost contains 150 mg of cobicistat.",[9],[23],"Tybost",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Darunavir\u002FCobicistat","Each tablet of Prezcobix contains 800 mg of darunavir and 150 mg of cobicistat.",[9],[29],"Prezcobix",{"type":18,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Rivaroxaban","Each tablet of Xarelto contains 10 mg of rivaroxaban.",[9],[35],"Xarelto",[37],{"name":38,"affiliation":5,"role":39},"Colleen M Hadigan, M.D.","PRINCIPAL_INVESTIGATOR",null,[42],{"facility":43,"status":40,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":40},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-77.10026,38.98067,{"lat":53,"lon":52},{"type":56,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100352095","phase-1-impact-of-steady-state-cobicistat-and-darunavircobicistat-on-the-pharmacokinetics-and-pharmacodynamics-of-oral-anticoagulants-rivaroxaban-apixaban-in-health-volunteers-100352095",true,"NCT03864406","Impact of Steady State Cobicistat and Darunavir\u002FCobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Health Volunteers","Impact of Steady State Cobicistat and Darunavir\u002FCobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Healthy Volunteers","* INCLUSION CRITERIA:\n\nA subject will be considered eligible for this study only if all of the following criteria are met:\n\n* Adults between the ages of 18 to 65 years.\n* Body mass index between 18 to 30 kg\u002FM(2).\n* Judged to be healthy based on medical history, physical examination, vital signs and clinical laboratory tests (liver function tests (LFTs: alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin less than or equal to upper limit of normal (ULN) (with the exception of participants with Gilbert's syndrome), albumin within normal limits (WNL)\\], eGFR \\> 90 mL\u002Fmin\u002F1.73 m(2), PLT\\>150,000\u002FmicroL, hemoglobin (Hgb) greater than or equal to 12 g\u002FdL, activated partial thromboplastin time (aPTT) less than or equal to ULN, partial thromboplastin time (PTT) less than or equal to ULN, international normalized ratio (INR) less than or equal to ULN.\n* Subject agrees to storage of specimens for future research.\n* Negative serum or urine pregnancy test for females of child-bearing potential.\n* For female subjects, willing to avoid pregnancy by (a) practicing abstinence or (b) using effective non-hormonal and\u002For barrier methods of birth control, as well as avoid breast feeding or providing breast milk to infant during the study period. (baseline visit up to end of study day 20 plus minus 3)\n* Willing to avoid engaging in activities such as contact sports, including extreme sports, that may increase the risk of bleeding through body injury or bruising, during the study period (baseline visit up to end of study day 20 plus minus 3)\n* Willingness to forgo drinking alcohol during the study period (baseline visit up to end of study day 20 plus minus 3)\n* Able to provide consent.\n\nEXCLUSION CRITERIA:\n\nA subject will be ineligible for this study if one, or more, of the following criteria are met:\n\n* HIV infection, as determined by standard serologic or virologic assays for HIV infection.\n* Laboratory evidence of active or chronic hepatitis A, B or C infection.\n* History or presence of any of the following:\n\n  * any major medical conditions that requires daily frequent medication or potentially impairs medication absorption, metabolism and elimination\n  * any other condition that may interfere with the interpretation of the study results, or not be in the best interest of the subject in the opinion of the Investigator.\n* Current participation in an ongoing investigational drug protocol or use of any investigational drug within 30 days (based on last dose received) prior to receipt of any study drugs\u002Fmedications.\n* History or presence of the following:\n\n  * bleeding\u002Fhematologic disorders (e.g., anemia, hemophilia, etc.),\n  * serious\u002Fmajor bleeding event (intracranial, gastrointestinal (GI), as assessed by subject interview), or\n  * current increased risk of bleeding\n  * for female subjects, menorrhagia\n* Planned invasive or surgical procedure within (prior to or following) 28 days of study participation.\n* Therapy with any prescription, over-the-counter, herbal, or holistic medications, including hormonal contraceptives by any route, within 5 half-lives of the agent prior to receipt of any study medications will not be permitted with the following exception:\n\nIntermittent or short-course therapy (\\\u003C14 days) with prescription, vaccines or over-the-counter medications will be reviewed by investigators on a case-by-case basis for potential drug interactions.\n\n* Inability to obtain venous access for sample collection.\n* Inability to swallow whole capsules and\u002For tablets.\n* Pregnant female.\n* Breastfeeding female.\n* The presence of persistent diarrhea or malabsorption that could interfere with the subject's ability to absorb drugs.\n* Illicit drug or alcohol use\n* Use of nicotine-containing tobacco products, including cigarettes, vaping and chewing tobacco.\n* Known hypersensitivity to rivaroxaban, apixaban, COBI or DRV.\n* History of documented hypersensitivity to sulfa allergy.\n* Organ transplant recipient.",false,"ALL","18 Years","65 Years",{"count":69,"type":70},12,"ACTUAL","INTERVENTIONAL",[73],"PHASE1","Background:\n\nRivaroxaban and apixaban are blood thinners. People with HIV may need to take them to treat or prevent blood clots. The anti-HIV drug darunavir (DRV) can increase the amount of these blood thinners in the body. This can cause bleeding or other health problems. The drug cobicistat (COBI) is used to help anti-HIV drugs work better. Researchers want to give healthy people DRV combined with COBI to learn how it affects rivaroxaban or apixaban blood levels.\n\nObjective:\n\nTo test blood levels of rivaroxaban or apixaban when taken with COBI and DRV\u002FCOBI.\n\nEligibility:\n\nHealthy volunteers ages 18-65\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nFasting blood and urine tests. (Urine tests will be performed in females of child-bearing potential only)\n\nParticipants will have 8 visits; 3 are long (about 10-12 hours) and 5 are about 1 hour. They include:\n\nBaseline and final visits:\n\nFasting blood and urine tests\n\nDay 1 visit (long day):\n\nFasting blood and urine tests\n\nCatheter placement: A needle will insert a small tube into the participant's arm vein. Blood will be drawn up to 10 times.\n\nDose of rivaroxaban or apixaban\n\nDay 2 visit (short day):\n\nFasting blood tests\n\nDose of COBI\n\nParticipants will receive a bottle containing COBI tablets to take at home.\n\nDay 7 (long day):\n\nFasting blood and urine tests\n\nCatheter placement: A needle will insert a small tube into the participant's arm vein. Blood will be drawn up to 10 times.\n\nDose of rivaroxaban or apixaban\n\nDose of COBI\n\nDay 8 (short day):\n\nFasting blood tests\n\nDose of DRV\u002FCOBI Participants will receive a bottle containing DRV\u002FCOBI tablets to take at home.\n\nDay 13 (long day):\n\nFasting blood and urine tests\n\nCatheter placement: A needle will insert a small tube into the participant s arm vein. Blood will be drawn up to 10 times.\n\nDose of rivaroxaban or apixaban\n\nDose of DRV\u002FCOBI\n\nDay 14 (short day):\n\nFasting blood tests\n\nParticipants will take COBI tablets daily at home on days 3-6, and DRV\u002FCOBI on days 9 -12 during the study. They will record doses and side effects.\n\nDuring the study, participants cannot:\n\nTake most medications.\n\nDrink alcohol, smoke, or vape\n\nEngage in activities such as contact and extreme sports",[76],"Healthy Volunteers",[78,79,80,81,82],"Antiretroviral Therapy","Human Immunodeficiency Disease","Drug-Drug Interactions","Thrombosis","Bleeding","COMPLETED","2023-11-29",{"date":86,"type":70},"2023-12-01",{"date":88,"type":70},"2019-06-04",{"date":90,"type":70},"2022-12-10",{"name":5,"class":6},1]