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
NCT ID: NCT04263350
Last Updated: 2021-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2020-02-26
2020-11-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Treatment A:Fixed- dose combination mini-tablet
Atazanavir/Cobicistat
Specified Dose on Specified Days
Treatment B: Separate products taken at the same time
Reyataz Atazanavir
Specified Dose on Specified Days
Cobicistat
Specified Dose on Specified Days
Interventions
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Atazanavir/Cobicistat
Specified Dose on Specified Days
Reyataz Atazanavir
Specified Dose on Specified Days
Cobicistat
Specified Dose on Specified Days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women and men must agree to follow specific methods of contraception, if applicable.
Exclusion Criteria
* 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
18 Years
49 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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PPD Development, LP
Austin, Texas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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AI424-567
Identifier Type: -
Identifier Source: org_study_id