Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
NCT ID: NCT01837719
Last Updated: 2014-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2013-04-30
2013-06-30
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
NONE
Study Groups
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Treatment A: Atazanavir + Cobicistat coadministered
Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
Atazanavir
300-mg capsule
Cobicistat
150-mg tablet
Treatment B: Atazanavir/Cobicistat FDC
Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
Atazanavir/Cobicistat FDC
Atazanavir 300-mg/cobicistat 150-mg FDC tablet
Treatment C: Atazanavir + Cobicistat coadministered
Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
Atazanavir
300-mg capsule
Cobicistat
150-mg tablet
Treatment D: Atazanavir/Cobicistat FDC
Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
Atazanavir/Cobicistat FDC
Atazanavir 300-mg/cobicistat 150-mg FDC tablet
Treatment E: Atazanavir/Cobicistat FDC
Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
Atazanavir/Cobicistat FDC
Atazanavir 300-mg/cobicistat 150-mg FDC tablet
Interventions
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Atazanavir
300-mg capsule
Cobicistat
150-mg tablet
Atazanavir/Cobicistat FDC
Atazanavir 300-mg/cobicistat 150-mg FDC tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index 18 to 32 kg/m\^2, inclusive
* Women of childbearing potential (WOCBP) who were not pregnant or breastfeeding
* WOCBP and men who are sexually active with WOCBP must use acceptable contraceptive methods
Exclusion Criteria
* Current or recent (within 3 months of study drug administration) gastrointestinal tract disease
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal tract surgery (including cholecystectomy) that could have an impact on the absorption of study drug
* Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
* Blood transfusion within 4 weeks of study drug administration
* Inability to tolerate oral medication, to be venipunctured, or to tolerate venous access
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination or electrocardiogram (ECG) findings, vital sign measurements, or results of clinical laboratory tests, beyond what is consistent with the target population
* Any of the following 12-lead ECG findings prior to study drug administration, confirmed by repeat testing
* PR ≥210 msec
* QRS ≥120 msec
* QT ≥500 msec
* QTcF ≥450 msec
* 2nd- or 3rd-degree A-V block or clinically relevant abnormalities in ECG findings
* Positive result on urine screening for drugs of abuse
* Positive result on blood screening for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 or -2 antibody
* Laboratory test results indicating levels outside of the ranges specified below:
* Alanine aminotransferase \>upper limit of normal (ULN)
* Aspartate aminotransferase \>ULN
* Total bilirubin \>ULN
* Serum creatinine \>ULN
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, Inc.
Austin, Texas, United States
Countries
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References
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Sevinsky H, Tao X, Wang R, Ravindran P, Sims K, Xu X, Jariwala N, Bertz R. A randomized trial in healthy subjects to assess the bioequivalence of an atazanavir/cobicistat fixed-dose combination tablet versus administration as separate agents. Antivir Ther. 2015;20(5):493-500. doi: 10.3851/IMP2913. Epub 2014 Oct 31.
Other Identifiers
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AI424-511
Identifier Type: -
Identifier Source: org_study_id