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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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04263350
Enrollment
34
Registered
2020-02-10
Start date
2020-02-26
Completion date
2020-11-17
Last updated
2021-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Healthy Participants

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.

Interventions

DRUGAtazanavir/Cobicistat

Specified Dose on Specified Days

DRUGReyataz Atazanavir

Specified Dose on Specified Days

DRUGCobicistat

Specified Dose on Specified Days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes

Inclusion 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/

Design outcomes

Primary

MeasureTime frame
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 ATVUp to Day 10
AUC(INF) of COBIUp to Day 10

Secondary

MeasureTime frame
Incidence of marked abnormalities in Electrocardiogram (ECG) recordingUp to 40 days
Incidence of Palatability questionnaire resultsUp to 40 days
Incidence of Serious Adverse Events (SAEs)Up to 70 days
Incidence of AEs leading to discontinuationUp to 40 days
Incidence of deathsUp to 40 days
Marked abnormalities in clinical laboratory test resultsUp to 40 days
Incidence of marked abnormalities in vital sign measurements: Blood PressureUp to 40 days
Incidence of marked abnormalities in vital sign measurements: Heart RateUp to 40 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026