Drug Interaction Study With Proton Pump Inhibitor
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Omeprazole 20 mg on the Pharmacokinetics of Atazanavir Administered With Ritonavir in Healthy Subjects
1 other identifier
interventional
56
1 country
1
Brief Summary
The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
Started Jun 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
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 25, 2006
CompletedFirst Posted
Study publicly available on registry
July 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedApril 8, 2011
June 1, 2008
2 months
July 25, 2006
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.
Secondary Outcomes (1)
PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.
Study Arms (8)
A1
ACTIVE COMPARATORA2
ACTIVE COMPARATORA3 I
EXPERIMENTALA3 II
EXPERIMENTALB1
ACTIVE COMPARATORB2
ACTIVE COMPARATORB3 I
EXPERIMENTALB3 II
EXPERIMENTALInterventions
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects between the ages of 18 to 50 years old with 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
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 25, 2006
First Posted
July 27, 2006
Study Start
June 1, 2006
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
April 8, 2011
Record last verified: 2008-06