Drug-Drug Interaction Study in Healthy Subjects

NCT ID: NCT00904059

Last Updated: 2011-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-07-31

Brief Summary

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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

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Pharmacokinetics and Safety in Healthy Subjects

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Treatment Group A

Group Type EXPERIMENTAL

BMS-650032

Intervention Type DRUG

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

Treatment Group B

Group Type EXPERIMENTAL

BMS-790052

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

BMS-650032

Intervention Type DRUG

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

BMS-790052

Intervention Type DRUG

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

Interventions

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BMS-650032

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

Intervention Type DRUG

BMS-790052

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

Intervention Type DRUG

BMS-650032

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

Intervention Type DRUG

BMS-790052

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Ppd Development, Lp

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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AI447-009

Identifier Type: -

Identifier Source: org_study_id

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