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

Phase 1

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: BMS-650032 or Placebo

• Registration Number: NCT00559247
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Study Start: 2008-01
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2010-09
• Disposition First Submitted: 2010-09-10
• Disposition First Submitted QC: 2010-09-10
• Last Update Submitted: 2010-09-10
• Disposition First Posted: 2010-09-13
• Last Update Posted: 2010-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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Exclusion Criteria

• Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
• Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
• Co-infection with HIV or HBV
• Women of childbearing potential

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
or Placebo - Dose Panel 2	BMS-650032 or Placebo	Oral Suspension 50 mg
or Placebo - Dose Panel 1	BMS-650032 or Placebo	Oral Suspension, 10 mg
or Placebo - Dose Panel 3	BMS-650032 or Placebo	Oral Suspension, 200 mg
or Placebo - Dose Panel 4	BMS-650032 or Placebo	Oral Suspension or Solution, 2.5 to 600 mg

Primary Outcome Measures

Name	Time	Method
Safety Outcome Measures	Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Measures	Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose
Pharmacodynamic Measures	Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing

Trial Locations

Locations (5)

West Coast Clinical Trials, Llc; 🇺🇸 Cypress, California, United States

Parexel International Corporation; 🇺🇸 Baltimore, Maryland, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Alamo Medical Research; 🇺🇸 San Antonio, Texas, United States