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

• Status: Not yet recruiting
• Trial end date: 2022-04-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Cobicistat

Criteria

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