Healthy Participants
Conditions
Keywords
Healthy Participants, Atazanavir, Cobicistat, Reyataz, Tybost, Evotaz
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.
Interventions
DRUGAtazanavir
Specified dose on specified days
DRUGCobicistat
Specified dose on specified days
DRUGAtazanavir/Cobicistat Mini-tablet
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number of participants with Adverse Events (AEs) | Up to 75 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 | — |
| Time of maximum observed plasma concentration (Tmax) | Up to 17 days | — |
| Number of participants with clinical laboratory abnormalities | Up to 17 days | — |
| Number of participants with vital sign abnormalities | Up to 17 days | — |
| Number of participants with electrocardiogram (ECG) 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 AEs leading to death | Up to 75 days | — |
| Apparent terminal plasma half-life (T-HALF) | Up to 17 days | — |
Countries
United States
Outcome results
None listed