Healthy Participants Clinical Trial
Official title:
An Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, 3-Sequence, Crossover Design, Relative Bioavailability Study Comparing the Pharmacokinetics of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations (ATV and COBI Oral Mini-tablets; 300 mg and 150 mg, Respectively) and the Coadministration of the Individual Reference Products (REYATAZ [Atazanavir Oral Powder] and TYBOST [Cobicistat Oral Tablet]; 300 mg and 150 mg, Respectively) in Healthy Adults Under Fed Conditions
| Verified date | October 2022 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | July 26, 2022 |
| Est. primary completion date | July 5, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 49 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution - 0001 | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to 17 days | ||
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 17 days | ||
| Secondary | Time of maximum observed plasma concentration (Tmax) | Up to 17 days | ||
| Secondary | Apparent terminal plasma half-life (T-HALF) | Up to 17 days | ||
| Secondary | Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T]) | Up to 17 days | ||
| Secondary | Observed plasma concentration at 24 hours (C24) | Up to 17 days | ||
| Secondary | Number of participants with Adverse Events (AEs) | Up to 75 days | ||
| Secondary | Number of participants with Serious Adverse Events (SAEs) | Up to 75 days | ||
| Secondary | Number of participants with AEs leading to discontinuation | Up to 75 days | ||
| Secondary | Number of participants with AEs leading to death | Up to 75 days | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to 17 days | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 17 days | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 17 days | ||
| Secondary | Changes in Taste Evaluation Questionnaire | Palatability evaluated on a scale from 1 (weak) to 9 (strong) | Up to 17 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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