Clinical trial
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
Name
AI424-578
Description
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.
Trial arms
Trial start
2022-05-13
Estimated PCD
2022-07-05
Trial end
2022-07-26
Status
Completed
Phase
Early phase I
Treatment
Atazanavir
Specified dose on specified days
Arms:
Treatment Sequence Group 1, Treatment Sequence Group 2, Treatment Sequence Group 3
Other names:
ATV, Reyataz
Cobicistat
Specified dose on specified days
Arms:
Treatment Sequence Group 1, Treatment Sequence Group 2, Treatment Sequence Group 3
Other names:
COBI, Tybost
Atazanavir/Cobicistat Mini-tablet
Specified dose on specified days
Arms:
Treatment Sequence Group 1, Treatment Sequence Group 2, Treatment Sequence Group 3
Other names:
Evotaz
Size
42
Primary endpoint
Maximum observed plasma concentration (Cmax)
Up to 17 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 17 days
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}
Updated at
2022-10-31
1 organization
3 products
1 indication
Product
AtazanavirIndication
Healthy ParticipantsProduct
CobicistatOrganization
Bristol-Myers SquibbProduct
Atazanavir + Cobicistat