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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT04263350

Run by

Bristol-Myers Squibb

People needed

34

Starts

2020-02-26

Expected to finish

2020-11-17

Last updated by the study team

2021-11-23

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• PPD Development, LP — Austin, Texas, United States

Full record on ClinicalTrials.gov

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