Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
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 wa...
Eligibility Criteria
Inclusion
- • Body Mass Index (BMI) of 18.0 to 32.0 kg/m\^2, inclusive. BMI = weight (kg)/\[height(m)\]\^2
Exclusion
- 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
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05236738
Start Date
May 13 2022
End Date
July 26 2022
Last Update
October 31 2022
Active Locations (1)
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1
Local Institution - 0001
Miami, Florida, United States, 33136