Drug-Drug Interaction Study in Healthy Subjects

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: BMS-790052; Drug: BMS-650032

• Registration Number: NCT00904059
• Lead Sponsor: Bristol-Myers Squibb

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

Study Timeline

• Study First Submitted: 2009-04-21
• Study Start: 2009-05
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-12
• Last Update Submitted: 2011-01-06
• Last Update Posted: 2011-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Group B	BMS-790052	-
Treatment Group A	BMS-650032	-
Treatment Group C	BMS-650032	Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg)
Treatment Group C	BMS-790052	Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin	Day 21 pharmacokinetic assessment

Secondary Outcome Measures

Name	Time	Method
To assess the safety, tolerability, and fractional excretion of sodium when BMS-709952 and BMS-650032 are co-administered	Within 24 hours post dose

Trial Locations

Locations (1)

Ppd Development, Lp; 🇺🇸 Austin, Texas, United States