Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-02-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of Atazanavir (ATV)
timeFrame: Up to Day 10
measure: Cmax of Cobicistat (COBI)
timeFrame: Up to Day 10
measure: Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV
timeFrame: Up to Day 10
measure: AUC(INF) of COBI
timeFrame: Up to Day 10
Secondary outcomes:
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 70 days
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 40 days
measure: Incidence of deaths
timeFrame: Up to 40 days
measure: Marked abnormalities in clinical laboratory test results
timeFrame: Up to 40 days
measure: Incidence of marked abnormalities in vital sign measurements: Blood Pressure
timeFrame: Up to 40 days
measure: Incidence of marked abnormalities in vital sign measurements: Heart Rate
timeFrame: Up to 40 days
measure: Incidence of marked abnormalities in Electrocardiogram (ECG) recording
timeFrame: Up to 40 days
measure: Incidence of Palatability questionnaire results
timeFrame: Up to 40 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: