Phase 1
N=64
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
Human Immunodeficiency Virus Type 1 (HIV-1)
Bottom Line
View on ClinicalTrials.gov: NCT01837719 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) of Atazanavir — 3832; 4104; 2585; 2941 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Atazanavir (Drug); Cobicistat (Drug); Atazanavir/Cobicistat FDC (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Atazanavir |
3832; 4104; 2585; 2941; 2545 | — |
| PRIMARY 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 |
32775; 34905; 25017; 27875; 25873; 33523 | — |
| SECONDARY Number of Participants Who Died and With Serious Adverse Events (SAEs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests |
3; 2; 3; 1; 1; 2 | — |
| SECONDARY Number of Participants With Out-of-range Intervals on Electrocardiogram (ECG) Findings |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Time of Maximum Observed Concentration (Tmax) of Atazanavir |
3.00; 2.50; 2.00; 2.00; 3.54 | — |
| SECONDARY Observed Concentration at 24 Hours (C24) of Atazanavir |
416; 449; 295; 337; 398 | — |
| SECONDARY Apparent Terminal Half-life (T-HALF) of Atazanavir |
7.54; 7.50; 7.25; 7.21; 7.14 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Cobicistat |
1321; 1348; 952; 1033; 1060 | — |
| SECONDARY Time of Maximum Observed Concentration (Tmax) of Cobicistat |
2.52; 2.52; 2.00; 2.00; 4.00 | — |
| SECONDARY 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 |
8738; 8866; 6541; 7204; 7916; 9045 | — |
| SECONDARY T-HALF of Cobicistat |
4.34; 4.33; 4.23; 4.09; 4.27 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01837719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.