Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Health Volunteers

Exclusion Criteria

• •A subject will be ineligible for this study if one, or more, of the following criteria are met:
• •HIV infection, as determined by standard serologic or virologic assays for HIV infection.
• •Laboratory evidence of active or chronic hepatitis A, B or C infection.
• •History or presence of any of the following:
• •* any major medical conditions that requires daily frequent medication or potentially impairs medication absorption, metabolism and elimination
• •* 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.
• •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/medications.
• •History or presence of the following:
• •* bleeding/hematologic disorders (e.g., anemia, hemophilia, etc.),
• •* serious/major bleeding event (intracranial, gastrointestinal (GI), as assessed by subject interview), or
• •* current increased risk of bleeding
• •* for female subjects, menorrhagia
• •Planned invasive or surgical procedure within (prior to or following) 28 days of study participation.
• •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:
• •Intermittent or short-course therapy (\<14 days) with prescription, vaccines or over-the-counter medications will be reviewed by investigators on a case-by-case basis for potential drug interactions.
• •Inability to obtain venous access for sample collection.
• •Inability to swallow whole capsules and/or tablets.
• •Pregnant female.
• •Breastfeeding female.
• •The presence of persistent diarrhea or malabsorption that could interfere with the subject's ability to absorb drugs.
• •Illicit drug or alcohol use
• •Use of nicotine-containing tobacco products, including cigarettes, vaping and chewing tobacco.
• •Known hypersensitivity to rivaroxaban, apixaban, COBI or DRV.
• •History of documented hypersensitivity to sulfa allergy.
• •Organ transplant recipient.