A Multiple Ascending Dose Study of BMS-790052 in Hepatitis C Virus (HCV) Infected Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00663208
First received: April 18, 2008
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

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 2

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pharmacodynamic Measures: Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels from baseline [ Time Frame: The primary endpoint for antiviral activity is decrease from baseline in plasma HCV RNA levels to Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PD-PK Relationship Measures: Assess relationship between antiviral activity and measures of exposure to BMS-790052 [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]
  • Safety Outcome Measures [ Time Frame: Safety and tolerability assessments will be performed for a period of 28 days after administration of multiple doses of BMS-790052 for 14 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic Measures [ Time Frame: Pharmacokinetic assessments will be done for a period of 5 days from Day 1, 72 hours after the last morning dose and at steady state ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1

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
Active Comparator: Group 2

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
Active Comparator: Group 3

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
Active Comparator: Group 4

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
Active Comparator: Group 5

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
Active Comparator: Group 6

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronically infected with HCV genotype 1
  • Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or HBV
  • 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
  • HIV and/or HBV positive
  • Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

WOCBP will be enrolled as in-patient for 16 days

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663208

Locations
United States, California
Advanced Clinical Res Inst
Anaheim, California, United States, 92801
West Coast Clinical Trials, Llc
Cypress, California, United States, 90630
United States, Florida
Elite Research Institute
Miami, Florida, United States, 33169
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
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
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00663208     History of Changes
Other Study ID Numbers: AI444-004
Study First Received: April 18, 2008
Last Updated: February 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 26, 2014