A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: Reyataz Atazanavir

Drug: Cobicistat

Drug: Atazanavir/Cobicistat

Study type

Interventional

Funder types

Industry

Identifiers

NCT04263350

AI424-567

Details and patient eligibility

About

The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.

Enrollment

34 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
Women and men must agree to follow specific methods of contraception, if applicable.

Exclusion Criteria:

History of a clinically significant drug rash or Stevens-Johnson Syndrome
History of Gilbert's Syndrome
Current or recent (within 3 months of administration) gastrointestinal disease that could impact upon the absorption of study treatment
Any major surgery within 4 weeks of study treatment administration
Any gastrointestinal surgery that could impact upon the absorption of study treatment

Other protocol-defined inclusion/exclusion criteria apply