Atazanavir Twice Daily
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00357721
First received: July 25, 2006
Last updated: April 5, 2011
Last verified: April 2011
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Purpose
The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Protease Inhibitor |
Drug: Atazanavir Sulphate |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Randomized, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics of Atazanavir Administered Twice-Daily in Health Subjects |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.
Secondary Outcome Measures:
- Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID
- Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform
- Assess the effect of atazanavir BID on metabolic parameters
- Assess the safety and tolerability of atazanavir when administered BID
| Estimated Enrollment: | 18 |
| Study Start Date: | June 2006 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A1 |
Drug: Atazanavir Sulphate
Capsules, Oral, 200 mg, twice daily, 7 days.
Other Name: Reyataz
|
| Active Comparator: A2 |
Drug: Atazanavir Sulphate
Capsules, Oral, 300 mg, twice daily, 8 days.
Other Name: Reyataz
|
| Active Comparator: A3 |
Drug: Atazanavir Sulphate
Capsules, Oral, 400 mg, twice daily, 9 days.
Other Name: Reyataz
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and female subjects between the ages of 18 to 45 years old with a BMI of 18 to 30 kg/m2
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357721
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357721
Locations
| United States, New Jersey | |
| Local Institution | |
| Hamilton, New Jersey, United States | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00357721 History of Changes |
| Other Study ID Numbers: | AI424-286 |
| Study First Received: | July 25, 2006 |
| Last Updated: | April 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 23, 2016