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

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559247
• Other study ID #: AI447-002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 15, 2007
• Last updated: September 10, 2010
• Start date: January 2008
• Est. completion date: July 2008

Study information

• Verified date: September 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• BMS-650032 or Placebo
Oral, Once daily, Single Dose

Locations

Country	Name	City	State
United States	Parexel International Corporation	Baltimore	Maryland
United States	West Coast Clinical Trials, Llc	Cypress	California
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Alamo Medical Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Outcome Measures		Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose	Yes
Secondary	Pharmacokinetic Measures		Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose	No
Secondary	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	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm