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
NCT ID: NCT05236738
Last Updated: 2022-10-31
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
42 participants
INTERVENTIONAL
2022-05-13
2022-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment Sequence Group 1
Atazanavir
Specified dose on specified days
Cobicistat
Specified dose on specified days
Atazanavir/Cobicistat Mini-tablet
Specified dose on specified days
Treatment Sequence Group 2
Atazanavir
Specified dose on specified days
Cobicistat
Specified dose on specified days
Atazanavir/Cobicistat Mini-tablet
Specified dose on specified days
Treatment Sequence Group 3
Atazanavir
Specified dose on specified days
Cobicistat
Specified dose on specified days
Atazanavir/Cobicistat Mini-tablet
Specified dose on specified days
Interventions
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Atazanavir
Specified dose on specified days
Cobicistat
Specified dose on specified days
Atazanavir/Cobicistat Mini-tablet
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
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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Local Institution - 0001
Miami, Florida, 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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AI424-578
Identifier Type: -
Identifier Source: org_study_id
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