NCT04263350

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

An Open-label, Randomized Crossover Study to Obtain a Preliminary Estimate of the Bioavailability of Atazanavir and Cobicistat When Administered in an Age-appropriate Fixed-Dose Combination Formulation Compared With Coadministration of the Age-appropriate Atazanavir and Cobicistat Individual Formulations and to Assess Preliminary Palatability/Acceptability in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Atazanavir/Cobicistat	Specified Dose on Specified Days
DRUG	Reyataz Atazanavir	Specified Dose on Specified Days
DRUG	Cobicistat	Specified Dose on Specified Days

Timeline

• Start date: 2020-02-26
• Primary completion: 2020-11-12
• Completion: 2020-11-17
• First posted: 2020-02-10
• Last updated: 2021-11-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study