search
Back to results

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

Primary Purpose

Healthy Participants

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atazanavir
Cobicistat
Atazanavir/Cobicistat Mini-tablet
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Participants focused on measuring Healthy Participants, Atazanavir, Cobicistat, Reyataz, Tybost, Evotaz

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Local Institution - 0001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Treatment Sequence Group 1

Treatment Sequence Group 2

Treatment Sequence Group 3

Arm Description

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])

Secondary Outcome Measures

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

Full Information

First Posted
February 2, 2022
Last Updated
October 27, 2022
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT05236738
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
July 5, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
Keywords
Healthy Participants, Atazanavir, Cobicistat, Reyataz, Tybost, Evotaz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Sequence Group 1
Arm Type
Experimental
Arm Title
Treatment Sequence Group 2
Arm Type
Experimental
Arm Title
Treatment Sequence Group 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atazanavir
Other Intervention Name(s)
ATV, Reyataz
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cobicistat
Other Intervention Name(s)
COBI, Tybost
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Atazanavir/Cobicistat Mini-tablet
Other Intervention Name(s)
Evotaz
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to 17 days
Title
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time Frame
Up to 17 days
Secondary Outcome Measure Information:
Title
Time of maximum observed plasma concentration (Tmax)
Time Frame
Up to 17 days
Title
Apparent terminal plasma half-life (T-HALF)
Time Frame
Up to 17 days
Title
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
Time Frame
Up to 17 days
Title
Observed plasma concentration at 24 hours (C24)
Time Frame
Up to 17 days
Title
Number of participants with Adverse Events (AEs)
Time Frame
Up to 75 days
Title
Number of participants with Serious Adverse Events (SAEs)
Time Frame
Up to 75 days
Title
Number of participants with AEs leading to discontinuation
Time Frame
Up to 75 days
Title
Number of participants with AEs leading to death
Time Frame
Up to 75 days
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 17 days
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 17 days
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
Up to 17 days
Title
Changes in Taste Evaluation Questionnaire
Description
Palatability evaluated on a scale from 1 (weak) to 9 (strong)
Time Frame
Up to 17 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0001
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

We'll reach out to this number within 24 hrs