A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects

Phase 1

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: BMS-791325; Drug: Placebo

• Registration Number: NCT00664625
• 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-791325 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: 2008-04-18
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Study Start: 2008-05
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Disposition First Submitted: 2010-09-10
• Disposition First Submitted QC: 2010-09-10
• Disposition First Posted: 2010-09-13
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-10-09

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 35 kg/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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BMS-791325	BMS-791325 (100 mg) or placebo match for (100 mg)
3	BMS-791325	BMS-791325 (900 mg) or placebo match for (900 mg)
1	Placebo	BMS-791325 (100 mg) or placebo match for (100 mg)
4	Placebo	BMS-791325 (potential dose between 10-800 mg) or placebo match for (10-800 mg)
2	Placebo	BMS-791325 (300 mg) or placebo match for (300 mg)
2	BMS-791325	BMS-791325 (300 mg) or placebo match for (300 mg)
3	Placebo	BMS-791325 (900 mg) or placebo match for (900 mg)
4	BMS-791325	BMS-791325 (potential dose between 10-800 mg) or placebo match for (10-800 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 (6)

Washington University School Of Medicine; 🇺🇸 St. Louis, Missouri, United States

University Of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Local Institution; 🇦🇷 Buenos Aires, Argentina

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

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

Advanced Clinical Res Inst; 🇺🇸 Anaheim, California, United States