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 — Phase 1, Completed, 34 participants, Bristol-Myers Squibb

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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

Registry	NCT04263350
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, basic science
Enrollment	34 (Actual)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Healthy Participants
Interventions	Atazanavir/Cobicistat, Reyataz Atazanavir, Cobicistat (Drug)
Dates	start 2020-02-26, primary completion 2020-11-12, completion 2020-11-17, first posted 2020-02-10, last updated 2021-11-23
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
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

Atazanavir/Cobicistat (Drug), also known as ATV/COBI: Specified Dose on Specified Days
Reyataz Atazanavir (Drug), also known as REYATAZ (ATV): Specified Dose on Specified Days
Cobicistat (Drug), also known as COBI: Specified Dose on Specified Days

+Outcome measures

Primary outcomes

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

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]

+Eligibility

Sex: All, ages: 18 Years to 49 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
PPD Development, LP	Austin, Texas	United States

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb