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Completed

NCT Number: NCT00722358

A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects

The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection

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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 2

Primary location

Local Institution, Santurce, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronically infected with HCV genotype 1
  • Treatment naive
  • HCV RNA viral load of ≥10*5 IU/mL
  • BMI 18 to 35kg/m²

Exclusion criteria

  • Women of childbearing potential (WOCBP)
  • Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
  • HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment
  • HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin
  • HIV and/or HBV positive
  • Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

Treatment and study plan

BMS-650032

Drug

Capsule, Oral, Q12h, 3/5 days

Panel 1: 200 mg

Panel 2: 400 mg

Panel 3: 600 mg

Placebo

Drug

Capsule, Oral, Q 12h, 3/5 days

Panel 1: matching placebo

Panel 2: matching placebo

Panel 3: matching placebo

Primary outcomes

  1. Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels from baseline. The primary endpoint for antiviral activity is decrease from baseline in plasma HCV RNA levels to Day 3/ or 5

    Time frame: To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period

Secondary outcomes

  1. PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032

    Time frame: 28 days after drug

  2. Safety Outcome Measures: Safety and tolerability assessments

    Time frame: will be performed for a period of 28 days after administration of multiple doses of BMS-650032 for 3/ or 5 days

  3. Pharmacokinetic Measures: Pharmacokinetic assessments

    Time frame: will be done on Day 1 for one dosing interval after the AM dose and on Day 3/ or 5 for 72 hours after the last AM dose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of BMS-650032 in Subjects Infected With Hepatitis C Virus Genotype 1

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 25, 2008
Registry last updated
Jun 27, 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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