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

An Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, 3-Sequence, Crossover Design, Relative Bioavailability Study Comparing the Pharmacokinetics of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations (ATV and COBI Oral Mini-tablets; 300 mg and 150 mg, Respectively) and the Coadministration of the Individual Reference Products (REYATAZ [Atazanavir Oral Powder] and TYBOST [Cobicistat Oral Tablet]; 300 mg and 150 mg, Respectively) in Healthy Adults Under Fed Conditions

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Atazanavir; Drug: Cobicistat; Drug: Atazanavir/Cobicistat Mini-tablet

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Sequence Group 1	Drug: Atazanavir; Specified dose on specified days; Other Names: Reyataz; ATV; Drug: Cobicistat; Specified dose on specified days; Other Names: Tybost; COBI; Drug: Atazanavir/Cobicistat Mini-tablet; Specified dose on specified days; Other Names: Evotaz
Experimental: Treatment Sequence Group 2	Drug: Atazanavir; Specified dose on specified days; Other Names: Reyataz; ATV; Drug: Cobicistat; Specified dose on specified days; Other Names: Tybost; COBI; Drug: Atazanavir/Cobicistat Mini-tablet; Specified dose on specified days; Other Names: Evotaz
Experimental: Treatment Sequence Group 3	Drug: Atazanavir; Specified dose on specified days; Other Names: Reyataz; ATV; Drug: Cobicistat; Specified dose on specified days; Other Names: Tybost; COBI; Drug: Atazanavir/Cobicistat Mini-tablet; Specified dose on specified days; Other Names: Evotaz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to 17 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])	Up to 17 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of maximum observed plasma concentration (Tmax)		Up to 17 days
Apparent terminal plasma half-life (T-HALF)		Up to 17 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])		Up to 17 days
Observed plasma concentration at 24 hours (C24)		Up to 17 days
Number of participants with Adverse Events (AEs)		Up to 75 days
Number of participants with Serious Adverse Events (SAEs)		Up to 75 days
Number of participants with AEs leading to discontinuation		Up to 75 days
Number of participants with AEs leading to death		Up to 75 days
Number of participants with clinical laboratory abnormalities		Up to 17 days
Number of participants with vital sign abnormalities		Up to 17 days
Number of participants with electrocardiogram (ECG) abnormalities		Up to 17 days
Changes in Taste Evaluation Questionnaire	Palatability evaluated on a scale from 1 (weak) to 9 (strong)	Up to 17 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): July 5, 2022
• Study Completion (Actual): July 26, 2022

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Atazanavir; Healthy Participants; Cobicistat; Reyataz; Tybost; Evotaz
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Cobicistat; Atazanavir Sulfate
• Other Study ID Numbers: AI424-578

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No