Local Institution - 0001
Miami, Florida, 33136, United States
Completed
NCT Number: 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
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–49 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Atazanavir
DrugSpecified dose on specified days
Other names: ATV, Reyataz
Cobicistat
DrugSpecified dose on specified days
Other names: COBI, Tybost
Atazanavir/Cobicistat Mini-tablet
DrugSpecified dose on specified days
Other names: Evotaz
Primary outcomes
-
Maximum observed plasma concentration (Cmax)
Time frame: Up to 17 days
-
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 17 days
Secondary outcomes
-
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 17 days
-
Apparent terminal plasma half-life (T-HALF)
Time frame: Up to 17 days
-
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
Time frame: Up to 17 days
-
Observed plasma concentration at 24 hours (C24)
Time frame: Up to 17 days
-
Number of participants with Adverse Events (AEs)
Time frame: Up to 75 days
-
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 75 days
-
Number of participants with AEs leading to discontinuation
Time frame: Up to 75 days
-
Number of participants with AEs leading to death
Time frame: Up to 75 days
-
Number of participants with clinical laboratory abnormalities
Time frame: Up to 17 days
-
Number of participants with vital sign abnormalities
Time frame: Up to 17 days
-
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 17 days
-
Changes in Taste Evaluation Questionnaire
Time frame: Up to 17 days
Palatability evaluated on a scale from 1 (weak) to 9 (strong)
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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
Important dates
- Study start
- 2022
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Feb 11, 2022
- Registry last updated
- Oct 31, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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