At a glance
ClinicalIndex Comparison Record- ✓Age 18-65 years
- ✓BMI 18-30 kg/m²
- ✓Healthy based on medical history, physical exam, vital signs, and clinical labs
- ✓Normal liver function (LFTs, albumin), eGFR >90, platelets >150,000, hemoglobin ≥12 g/dL, aPTT and PTT ≤ULN, INR ≤ULN
- ✕HIV infection
- ✕Active or chronic hepatitis A, B, or C infection
- ✕Major medical conditions requiring daily frequent medication or impairing medication absorption, metabolism, or elimination
- ✕Bleeding or hematologic disorders (anemia, hemophilia), serious/major bleeding events (intracranial, GI), current increased bleeding risk, or menorrhagia in females
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Cobicistat, Darunavir/Cobicistat, and 1 other intervention for Healthy Volunteers. Completed, enrolled 12 participants across 1 site.
Detailed Summary
Background: Rivaroxaban 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. Objective: To test blood levels of rivaroxaban or apixaban when taken with COBI and DRV/COBI. Eligibility: Healthy volunteers ages 18-65 Design: Participants will be screened with: Medical history Physical exam Fasting blood and urine tests. (Urine tests will be performed in females of child-bearing potential only) Participants will have 8 visits; 3 are long (about 10-12 hours) and 5 are about 1 hour. They include: Baseline and final visits: Fasting blood and urine tests Day 1 visit (long day): Fasting blood and urine tests Catheter placement: A needle will insert a small tube into the participant's arm vein. Blood will be drawn up to 10 times. Dose of rivaroxaban or apixaban Day 2 visit (short day): Fasting blood tests Dose of COBI Participants will receive a bottle containing COBI tablets to take at home. Day 7 (long day): Fasting blood and urine tests Catheter placement: A needle will insert a small tube into the participant's arm vein. Blood will be drawn up to 10 times. Dose of rivaroxaban or apixaban Dose of COBI Day 8 (short day): Fasting blood tests Dose of DRV/COBI Participants will receive a bottle containing DRV/COBI tablets to take at home. Day 13 (long day): Fasting blood and urine tests Catheter placement: A needle will insert a small tube into the participant s arm vein. Blood will be drawn up to 10 times. Dose of rivaroxaban or apixaban Dose of DRV/COBI Day 14 (short day): Fasting blood tests Participants will take COBI tablets daily at home on days 3-6, and DRV/COBI on days 9 -12 during the study. They will record doses and side effects. During the study, participants cannot: Take most medications. Drink alcohol, smoke, or vape Engage in activities such as contact and extreme sports
Study Details
Timeline
Interventions
Each tablet of Tybost contains 150 mg of cobicistat.
Each tablet of Prezcobix contains 800 mg of darunavir and 150 mg of cobicistat.
Each tablet of Xarelto contains 10 mg of rivaroxaban.