Drug-Drug Interaction Study in Healthy Subjects

January 6, 2011 updated by: Bristol-Myers Squibb

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

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

Study Overview

Detailed Description

Pharmacokinetics and Safety in Healthy Subjects

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Austin, Texas, United States, 78744
        • PPD Development, LP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group A
Capsules, Oral, 600 mg, Q12h, Days 1-7
Capsules, Oral, 200 mg, Q12h, Days 8-21
Experimental: Treatment Group B
Capsules, Oral, 60 mg, Q24h, Days 1-7
Capsules, Oral, 30 mg, Q24h, Days 8-21
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)
Capsules, Oral, 600 mg, Q12h, Days 1-7
Capsules, Oral, 200 mg, Q12h, Days 8-21
Capsules, Oral, 60 mg, Q24h, Days 1-7
Capsules, Oral, 30 mg, Q24h, Days 8-21

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin
Time Frame: Day 21 pharmacokinetic assessment
Day 21 pharmacokinetic assessment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 19, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2011

Last Update Submitted That Met QC Criteria

January 6, 2011

Last Verified

December 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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