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

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

U.S. FDA Resources

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

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

More Information

Additional Information:

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

Investigator Inquiry form 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

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nettles RE, Gao M, Bifano M, Chung E, Persson A, Marbury TC, Goldwater R, DeMicco MP, Rodriguez-Torres M, Vutikullird A, Fuentes E, Lawitz E, Lopez-Talavera JC, Grasela DM. Multiple ascending dose study of BMS-790052, a nonstructural protein 5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1. Hepatology. 2011 Dec;54(6):1956-65.

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 May 23, 2013