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
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
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedStudy Start
First participant enrolled
May 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2022
CompletedOctober 31, 2022
October 1, 2022
2 months
February 2, 2022
October 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (12)
Time of maximum observed plasma concentration (Tmax)
Up to 17 days
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
Number of participants with Adverse Events (AEs)
Up to 75 days
- +7 more secondary outcomes
Study Arms (3)
Treatment Sequence Group 1
EXPERIMENTALTreatment Sequence Group 2
EXPERIMENTALTreatment Sequence Group 3
EXPERIMENTALInterventions
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) of 18.0 to 32.0 kg/m\^2, inclusive. BMI = weight (kg)/\[height(m)\]\^2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Miami, Florida, 33136, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 2, 2022
First Posted
February 11, 2022
Study Start
May 13, 2022
Primary Completion
July 5, 2022
Study Completion
July 26, 2022
Last Updated
October 31, 2022
Record last verified: 2022-10