Status:
COMPLETED
Drug-Drug Interaction Study in Healthy Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
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
Detailed Description
Pharmacokinetics and Safety in Healthy Subjects
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00904059
Start Date
May 1 2009
End Date
July 1 2009
Last Update
January 7 2011
Active Locations (1)
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1
Ppd Development, Lp
Austin, Texas, United States, 78744