Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects
1 other identifier
interventional
14
1 country
1
Brief Summary
The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
Started Sep 2006
Shorter than P25 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2006
CompletedFirst Posted
Study publicly available on registry
August 10, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedApril 8, 2011
June 1, 2008
2 months
August 9, 2006
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.
Secondary Outcomes (2)
To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.
To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure
Study Arms (5)
A
ACTIVE COMPARATORB
ACTIVE COMPARATORC
ACTIVE COMPARATORD
ACTIVE COMPARATORE
ACTIVE COMPARATORInterventions
Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.
Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.
Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Hamilton, New Jersey, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 9, 2006
First Posted
August 10, 2006
Study Start
September 1, 2006
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
April 8, 2011
Record last verified: 2008-06