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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00663208 |
The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-790052 and during the follow-up period in subjects with chronic hepatitis C infection
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C |
Drug: BMS-790052 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of BMS-790052 in Subjects Infected With Hepatitis C Virus Genotype 1 |
Estimated Enrollment: | 60 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group 1: Active Comparator
BMS-790052 (1 mg), once daily or Matching Placebo, once daily |
Drug: BMS-790052
Capsule, Oral, Approximately 182 days from initial dosing
Drug: Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
|
Group 2: Active Comparator
BMS-790052 (10 mg), once daily or Matching Placebo, once daily |
Drug: BMS-790052
Capsule, Oral, Approximately 182 days from initial dosing
Drug: Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
|
Group 3: Active Comparator
BMS-790052 (1-100 mg), once or twice daily or Matching Placebo, once or twice daily |
Drug: BMS-790052
Capsule, Oral, Approximately 182 days from initial dosing
Drug: Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
|
Group 4: Active Comparator
BMS-790052 (1-100 mg), once or twice daily or Matching Placebo, once or twice daily |
Drug: BMS-790052
Capsule, Oral, Approximately 182 days from initial dosing
Drug: Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
|
Group 5: Active Comparator
Group 5: Active Comparator BMS-790052 (1-100 mg), once or twice daily or Matching Placebo, once or twice daily |
Drug: BMS-790052
Capsule, Oral, Approximately 182 days from initial dosing
Drug: Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
|
Group 6: Active Comparator
Group 6: Active Comparator BMS-790052 (1-100 mg), once or twice daily or Matching Placebo, once or twice daily |
Drug: BMS-790052
Capsule, Oral, Approximately 182 days from initial dosing
Drug: Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
WOCBP will be enrolled as in-patient for 16 days
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 | |
Elite Research Institute | |
Miami, Florida, United States, 33169 | |
United States, Maryland | |
Parexel International Corporation | |
Baltimore, Maryland, United States, 21225 | |
United States, Texas | |
Alamo Medical Research | |
San Antonio, Texas, United States, 78215 | |
Puerto Rico | |
Local Institution | |
Santurce, Puerto Rico, 00909 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | AI444-004 |
Study First Received: | April 18, 2008 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00663208 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis, Viral, Human Hepatitis C Antiviral Agents Hepatitis C, Chronic |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases Digestive System Diseases |
Flaviviridae Infections Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |