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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Atazanavir/Cobicistat; Drug: Reyataz Atazanavir; Drug: Cobicistat

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Development, LP

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A:Fixed- dose combination mini-tablet	Drug: Atazanavir/Cobicistat; Specified Dose on Specified Days; Other Names: ATV/COBI
Experimental: Treatment B: Separate products taken at the same time	Drug: Reyataz Atazanavir; Specified Dose on Specified Days; Other Names: REYATAZ (ATV); Drug: Cobicistat; Specified Dose on Specified Days; Other Names: COBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax) of Atazanavir (ATV)	Up to Day 10
Cmax of Cobicistat (COBI)	Up to Day 10
Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV	Up to Day 10
AUC(INF) of COBI	Up to Day 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Serious Adverse Events (SAEs)	Up to 70 days
Incidence of AEs leading to discontinuation	Up to 40 days
Incidence of deaths	Up to 40 days
Marked abnormalities in clinical laboratory test results	Up to 40 days
Incidence of marked abnormalities in vital sign measurements: Blood Pressure	Up to 40 days
Incidence of marked abnormalities in vital sign measurements: Heart Rate	Up to 40 days
Incidence of marked abnormalities in Electrocardiogram (ECG) recording	Up to 40 days
Incidence of Palatability questionnaire results	Up to 40 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): February 26, 2020
• Primary Completion (Actual): November 12, 2020
• Study Completion (Actual): November 17, 2020

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Healthy Participants
• Additional Relevant MeSH Terms: 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: AI424-567

Drug and device information, study documents

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