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Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Human Immunodeficiency Virus Type 1 (HIV-1)

Intervention: Atazanavir (Drug); Cobicistat (Drug); Atazanavir/Cobicistat FDC (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.

Clinical Details

Official title: A Randomized, 5-Period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of Atazanavir When Co-Administered With Cobicistat as a Fixed Dose Combination Relative to the Single Agents Following a Light Meal, the Relative Bioavailability of Atazanavir When Co-Administered With Cobicistat as a Fixed Dose Combination Relative to the Single Agents Under Fasted Conditions, and the Effect of Food on the Bioavailability of Atazanavir in the Fixed Dose Combination

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Maximum Observed Plasma Concentration (Cmax) of Atazanavir

Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and From Time 0 to Infinity (AUC[INF]) for Atazanavir

Secondary outcome:

Number of Participants Who Died and With Serious Adverse Events (SAEs)

Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests

Number of Participants With Out-of-range Intervals on Electrocardiogram (ECG) Findings

Time of Maximum Observed Concentration (Tmax) of Atazanavir

Observed Concentration at 24 Hours (C24) of Atazanavir

Apparent Terminal Half-life (T-HALF) of Atazanavir

Maximum Observed Plasma Concentration (Cmax) of Cobicistat

Time of Maximum Observed Concentration (Tmax) of Cobicistat

Area Under the Concentration Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and Area Under the Concentration Curve From Time 0 to Infinity (AUC[INF]) of Cobicistat

T-HALF of Cobicistat

Eligibility

Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Healthy men and women, ages 18 to 49 years

- 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 Key Exclusion Criteria:

- Any significant acute or chronic medical illness

- 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

Locations and Contacts

Ppd Development, Inc., Austin, Texas 78744, United States
Additional Information

Starting date: April 2013
Last updated: August 19, 2014

Page last updated: August 23, 2015

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