Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development, LP

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atazanavir/cobicistat

Drug

Specified Dose on Specified Days

Other names: ATV/COBI

Reyataz Atazanavir

Drug

Specified Dose on Specified Days

Other names: REYATAZ (ATV)

Cobicistat

Drug

Specified Dose on Specified Days

Other names: COBI

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of Atazanavir (ATV)

    Time frame: Up to Day 10

  2. Cmax of Cobicistat (COBI)

    Time frame: Up to Day 10

  3. Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV

    Time frame: Up to Day 10

  4. AUC(INF) of COBI

    Time frame: Up to Day 10

Secondary outcomes

  1. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 70 days

  2. Incidence of AEs leading to discontinuation

    Time frame: Up to 40 days

  3. Incidence of deaths

    Time frame: Up to 40 days

  4. Marked abnormalities in clinical laboratory test results

    Time frame: Up to 40 days

  5. Incidence of marked abnormalities in vital sign measurements: Blood Pressure

    Time frame: Up to 40 days

  6. Incidence of marked abnormalities in vital sign measurements: Heart Rate

    Time frame: Up to 40 days

  7. Incidence of marked abnormalities in Electrocardiogram (ECG) recording

    Time frame: Up to 40 days

  8. Incidence of Palatability questionnaire results

    Time frame: Up to 40 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2020
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.