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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Atazanavir; Drug: Atazanavir/Cobicistat Mini-tablet; Drug: Cobicistat

Study type: Interventional

Funder types: Industry

Identifiers

NCT05236738

AI424-578

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

42 participants in 3 patient groups

Treatment Sequence Group 1

Experimental group

Treatment:

Drug: Cobicistat

Drug: Atazanavir/Cobicistat Mini-tablet

Drug: Atazanavir

Treatment Sequence Group 2

Experimental group

Treatment:

Drug: Cobicistat

Drug: Atazanavir/Cobicistat Mini-tablet

Drug: Atazanavir

Treatment Sequence Group 3

Experimental group

Treatment:

Drug: Cobicistat

Drug: Atazanavir/Cobicistat Mini-tablet

Drug: Atazanavir