Drug-Drug Interaction Study in Healthy Subjects

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00904059

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: BMS-650032 Drug: BMS-790052 Drug: BMS-650032 Drug: BMS-790052	Phase 1

Detailed Description

Pharmacokinetics and Safety in Healthy Subjects

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group A	Drug: BMS-650032 Capsules, Oral, 600 mg, Q12h, Days 1-7
Experimental: Treatment Group B	Drug: BMS-790052 Capsules, Oral, 60 mg, Q24h, Days 1-7
Experimental: Treatment Group C Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg)	Drug: BMS-650032 Capsules, Oral, 200 mg, Q12h, Days 8-21 Drug: BMS-790052 Capsules, Oral, 30 mg, Q24h, Days 8-21

Arm

Intervention/Treatment

Experimental: Treatment Group A

Drug: BMS-650032

Capsules, Oral, 600 mg, Q12h, Days 1-7

Experimental: Treatment Group B

Drug: BMS-790052

Capsules, Oral, 60 mg, Q24h, Days 1-7

Experimental: Treatment Group C

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

Drug: BMS-650032

Capsules, Oral, 200 mg, Q12h, Days 8-21

Drug: BMS-790052

Capsules, Oral, 30 mg, Q24h, Days 8-21

Outcome Measures

Primary Outcome Measures

Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin [Day 21 pharmacokinetic assessment]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ppd Development, Lp	Austin	Texas	United States	78744

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00904059

Other Study ID Numbers:

AI447-009

First Posted:

May 19, 2009

Last Update Posted:

Jan 7, 2011

Last Verified:

Dec 1, 2010

Additional relevant MeSH terms:

Hepatitis C

Asunaprevir

Study Results

No Results Posted as of Jan 7, 2011