A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT05236738
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
• Body Mass Index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. BMI = weight (kg)/[height(m)]^2
Exclusion Criteria
- Significant acute or chronic medical illness
- History of a clinically significant drug rash, Stevens-Johnson Syndrome or Gilbert's Syndrome
- Inability to swallow oral medication
- Major surgery within 4 weeks of study treatment administration
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Sequence Group 1 Cobicistat - Treatment Sequence Group 3 Cobicistat - Treatment Sequence Group 1 Atazanavir/Cobicistat Mini-tablet - Treatment Sequence Group 2 Atazanavir/Cobicistat Mini-tablet - Treatment Sequence Group 3 Atazanavir/Cobicistat Mini-tablet - Treatment Sequence Group 1 Atazanavir - Treatment Sequence Group 2 Cobicistat - Treatment Sequence Group 2 Atazanavir - Treatment Sequence Group 3 Atazanavir -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Up to 17 days Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) Up to 17 days
- Secondary Outcome Measures
Name Time Method Apparent terminal plasma half-life (T-HALF) Up to 17 days Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T]) Up to 17 days Observed plasma concentration at 24 hours (C24) Up to 17 days Time of maximum observed plasma concentration (Tmax) Up to 17 days Number of participants with Adverse Events (AEs) Up to 75 days Number of participants with vital sign abnormalities Up to 17 days Changes in Taste Evaluation Questionnaire Up to 17 days Palatability evaluated on a scale from 1 (weak) to 9 (strong)
Number of participants with clinical laboratory abnormalities Up to 17 days Number of participants with electrocardiogram (ECG) abnormalities Up to 17 days Number of participants with Serious Adverse Events (SAEs) Up to 75 days Number of participants with AEs leading to discontinuation Up to 75 days Number of participants with AEs leading to death Up to 75 days
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Miami, Florida, United States