A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00664625
First received: April 18, 2008
Last updated: January 6, 2011
Last verified: December 2009
  Purpose

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection


Condition Intervention Phase
Chronic Hepatitis C
Drug: BMS-791325
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-791325 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety Outcome Measures [ Time Frame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic Measures [ Time Frame: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose ] [ Designated as safety issue: No ]
  • Pharmacodynamic Measures [ Time Frame: Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing ] [ Designated as safety issue: No ]

Enrollment: 24
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
Experimental: 1

BMS-791325 (100 mg)

or

placebo match for (100 mg)

Drug: BMS-791325
Capsules, Oral, Once Daily, Single Dose
Drug: Placebo
Capsules, Oral, Once Daily, Single Dose
Experimental: 2

BMS-791325 (300 mg)

or

placebo match for (300 mg)

Drug: BMS-791325
Capsules, Oral, Once Daily, Single Dose
Drug: Placebo
Capsules, Oral, Once Daily, Single Dose
Experimental: 3

BMS-791325 (900 mg)

or

placebo match for (900 mg)

Drug: BMS-791325
Capsules, Oral, Once Daily, Single Dose
Drug: Placebo
Capsules, Oral, Once Daily, Single Dose
Experimental: 4

BMS-791325 (potential dose between 10-800 mg)

or

placebo match for (10-800 mg)

Drug: BMS-791325
Capsules, Oral, Once Daily, Single Dose
Drug: Placebo
Capsules, Oral, Once Daily, Single Dose

  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
  • HCV RNA viral load of ≥10*5* IU/mL
  • BMI 18 to 35 kg/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
  • Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
  • Co-infection with HIV or HBV
  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: NCT00664625

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, Missouri
Washington University School Of Medicine
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Alamo Medical Research
San Antonio, Texas, United States, 78215
Argentina
Local Institution
Buenos Aires, Argentina, C1181
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00664625     History of Changes
Other Study ID Numbers: AI443-002
Study First Received: April 18, 2008
Last Updated: January 6, 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 28, 2014