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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00663208

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 II

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

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

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 ]

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

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

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

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, California
Advanced Clinical Res Inst	Recruiting
Anaheim, California, United States, 92801
Contact: Michael Demicco, Site 004 714-774-7777
West Coast Clinical Trials, Llc	Recruiting
Cypress, California, United States, 90630
Contact: Michelle D. Ababa, Site 005 714-252-0700
United States, Connecticut
Yale University School Of Medicine	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Joseph K. Lim, Site 009 203-737-6063
United States, Florida
Orlando Clinical Research Center	Recruiting
Orlando, Florida, United States, 32809
Contact: Thomas C. Marbury, Site 001 407-240-7878
Elite Research Institute	Recruiting
Miami, Florida, United States, 33169
Contact: Ernesto Fuentes, Site 010 866-371-8333
United States, Maryland
Parexel International Corporation	Recruiting
Baltimore, Maryland, United States, 21225
Contact: D. Ronald Goldwater, Site 002 410-350-7926
United States, Texas
Alamo Medical Research	Recruiting
San Antonio, Texas, United States, 78215
Contact: Eric J. Lawitz, Site 003 210-253-3426
United States, Virginia
University Of Virginia Digestive Health Center Of Excellence	Suspended
Charlottesville, Virginia, United States, 22908
Puerto Rico
Local Institution	Recruiting
Santurce, Puerto Rico, 00909
Contact: Site 006

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI444-004
Study First Received:	April 18, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00663208
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009