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Sponsored by: |
Bristol-Myers Squibb |
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00559247 |
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
Condition | Intervention | Phase |
Chronic Hepatitis C |
Drug: BMS-650032 or Placebo |
Phase I Phase II |
MedlinePlus related topics: | Hepatitis Hepatitis C |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 24 |
Study Start Date: | January 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
or Placebo - Dose Panel 1: Experimental
Oral Suspension, 10 mg
|
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose
|
or Placebo - Dose Panel 2: Experimental
Oral Suspension 50 mg
|
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose
|
or Placebo - Dose Panel 3: Experimental
Oral Suspension, 200 mg
|
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose
|
or Placebo - Dose Panel 4: Experimental
Oral Suspension or Solution, 2.5 to 600 mg
|
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose
|
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
West Coast Clinical Trials, Llc | |||||
Cypress, California, United States, 90630 | |||||
United States, Florida | |||||
Orlando Clinical Research Center | |||||
Orlando, Florida, United States, 32809 | |||||
United States, Maryland | |||||
Parexel International Corporation | |||||
Baltimore, Maryland, United States, 21225 | |||||
United States, Minnesota | |||||
Mayo Clinic | |||||
Rochester, Minnesota, United States, 55905 | |||||
United States, Texas | |||||
Alamo Medical Research | |||||
San Antonio, Texas, United States, 78215 |
Bristol-Myers Squibb |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
BMS Clinical Trials Disclosure 
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For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm 
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Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | AI447-002 |
First Received: | November 15, 2007 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00559247 |
Health Authority: | United States: Food and Drug Administration |
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