A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT04263350
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
- Women and men must agree to follow specific methods of contraception, if applicable.
Exclusion Criteria
- History of a clinically significant drug rash or Stevens-Johnson Syndrome
- History of Gilbert's Syndrome
- Current or recent (within 3 months of administration) gastrointestinal disease that could impact upon the absorption of study treatment
- Any major surgery within 4 weeks of study treatment administration
- Any gastrointestinal surgery that could impact upon the absorption of study treatment
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A:Fixed- dose combination mini-tablet Atazanavir/Cobicistat - Treatment B: Separate products taken at the same time Reyataz Atazanavir - Treatment B: Separate products taken at the same time Cobicistat -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV Up to Day 10 Cmax of Cobicistat (COBI) Up to Day 10 Maximum observed plasma concentration (Cmax) of Atazanavir (ATV) Up to Day 10 AUC(INF) of COBI Up to Day 10
- Secondary Outcome Measures
Name Time Method Incidence of AEs leading to discontinuation Up to 40 days Incidence of Serious Adverse Events (SAEs) Up to 70 days Incidence of deaths Up to 40 days Incidence of marked abnormalities in vital sign measurements: Blood Pressure Up to 40 days Marked abnormalities in clinical laboratory test results Up to 40 days Incidence of marked abnormalities in vital sign measurements: Heart Rate Up to 40 days Incidence of marked abnormalities in Electrocardiogram (ECG) recording Up to 40 days Incidence of Palatability questionnaire results Up to 40 days
Trial Locations
- Locations (1)
PPD Development, LP
🇺🇸Austin, Texas, United States