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

NCT04263350 | Completed Phase 1 FDA Drug

• 1 other identifier: AI424-567
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

Study Arms (2)

Treatment A:Fixed- dose combination mini-tablet

EXPERIMENTAL

Drug: Atazanavir/Cobicistat

Treatment B: Separate products taken at the same time

EXPERIMENTAL

Drug: Reyataz Atazanavir; Drug: Cobicistat

Interventions

Atazanavir/Cobicistat DRUG

Specified Dose on Specified Days

Also known as: ATV/COBI

Treatment A:Fixed- dose combination mini-tablet

Reyataz Atazanavir DRUG

Specified Dose on Specified Days

Also known as: REYATAZ (ATV)

Treatment B: Separate products taken at the same time

Cobicistat DRUG

Specified Dose on Specified Days

Also known as: COBI

Treatment B: Separate products taken at the same time

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

Related Links

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

MeSH Terms

Interventions

Atazanavir Sulfate; Cobicistat

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 10, 2020
• Study Start: February 26, 2020
• Primary Completion: November 12, 2020
• Study Completion: November 17, 2020
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

US (1)