Clinical trial NCT05236738: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy Participants
Atazanavir
Cobicistat
Reyataz
Tybost
Evotaz
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 17 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
timeFrame: Up to 17 days
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 17 days
measure: Apparent terminal plasma half-life (T-HALF)
timeFrame: Up to 17 days
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
timeFrame: Up to 17 days
measure: Observed plasma concentration at 24 hours (C24)
timeFrame: Up to 17 days
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 75 days
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to 75 days
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 75 days
measure: Number of participants with AEs leading to death
timeFrame: Up to 75 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 17 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 17 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 17 days
measure: Changes in Taste Evaluation Questionnaire
timeFrame: Up to 17 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Local Institution - 0001
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: