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Drug-Drug Interaction Study in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00904059
First Posted: May 19, 2009
Last Update Posted: January 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
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 Intervention Phase
Hepatitis C Drug: BMS-650032 Drug: BMS-790052 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin [ Time Frame: 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 [ Time Frame: Within 24 hours post dose ]

Enrollment: 28
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Pharmacokinetics and Safety in Healthy Subjects
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904059


Locations
United States, Texas
Ppd Development, Lp
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00904059     History of Changes
Other Study ID Numbers: AI447-009
First Submitted: April 21, 2009
First Posted: May 19, 2009
Last Update Posted: January 7, 2011
Last Verified: December 2010

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases