Drug-Drug Interaction Study in Healthy Subjects
Open-Label, Randomized, Multiple-Dose, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of BMS-790052 and BMS-650032 Co-administered in Healthy Subjects
1 other identifier
interventional
28
1 country
1
Brief Summary
The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and BMS-650032 when co-administered and when administered alone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2009
Shorter than P25 for phase_1
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
April 21, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedFirst Posted
Study publicly available on registry
May 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJanuary 7, 2011
December 1, 2010
2 months
April 21, 2009
January 6, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin
Day 21 pharmacokinetic assessment
Secondary Outcomes (1)
To assess the safety, tolerability, and fractional excretion of sodium when BMS-709952 and BMS-650032 are co-administered
Within 24 hours post dose
Study Arms (3)
Treatment Group A
EXPERIMENTALTreatment Group B
EXPERIMENTALTreatment Group C
EXPERIMENTALTreatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg)
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects aged 18 to 49 years
- Females who are not of childbearing potential, pregnant or breastfeeding
- Subject Body Mass Index (BMI) of 18 to 32 kg/m²
You may not qualify if:
- Women of child bearing potential
- Male subjects who have sex with women who are unwilling to agree to practice male barrier contraception during study participation and for a least 12 weeks following dosing
- Any significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Prior exposure to BMS-650032 or BMS-790052
- Positive for HIV or HCV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ppd Development, Lp
Austin, Texas, 78744, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition 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
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 21, 2009
First Posted
May 19, 2009
Study Start
May 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
January 7, 2011
Record last verified: 2010-12