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NCT Number: NCT00971308

Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus

The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advanced Clinical Research Institute, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1
  • HCV RNA viral load of ≤10*5* IU/mL (100,000 IU/mL)
  • Body Mass Index (BMI) of 18 to 35 kg/m², inclusive

Exclusion criteria

  • Women who are pregnant or breast feeding
  • Any significant acute or chronic medical illness which is not stable or is not controlled with medication or is not consistent with Hepatitis C infection
  • Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study

Treatment and study plan

BMS-824393

Drug

Capsule, Oral, 50mg, Once Daily, 3 days

Primary outcomes

  1. Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects

    Time frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

Secondary outcomes

  1. To assess the change in HCV RNA over time during three days of dosing with BMS- 824393 and during the follow-up period in chronically genotype subtype 1a and 1b HCV infected subjects

    Time frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

  2. To assess potential differences in antiviral effect in genotype subtypes (1a versus 1b)

    Time frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

  3. To assess the safety and tolerability of multiple oral doses of BMS-824393

    Time frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Open Label, Multiple-Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of BMS-824393 in Treatment Naive Subjects Infected With Hepatitis C Virus Genotype 1

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 3, 2009
Registry last updated
Jan 25, 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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