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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236738
• Other study ID #: AI424-578
• Status: Completed
• Phase: Phase 1
• Start date: May 13, 2022
• Est. completion date: July 26, 2022

Study information

• Verified date: October 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 26, 2022
• Est. primary completion date: July 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants
• Malnutrition

Intervention

Drug:
• Atazanavir
Specified dose on specified days
• Cobicistat
Specified dose on specified days
• Atazanavir/Cobicistat Mini-tablet
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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