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Completed

NCT Number: NCT00904059

Drug-Drug Interaction Study 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

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ppd Development, Lp

Austin, Texas, 78744, United States

About this study

Pharmacokinetics and Safety in Healthy Subjects

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-650032

Drug

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

BMS-790052

Drug

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

Primary outcomes

  1. Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin

    Time frame: Day 21 pharmacokinetic assessment

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 19, 2009
Registry last updated
Jan 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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