A Single Ascending Dose Study of BMS-790052 in HCV Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00546715
First received: October 17, 2007
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-790052 in subjects with chronic hepatitis C infection


Condition Intervention Phase
Chronic Hepatitis C
Drug: BMS-790052
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group 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-790052 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:
  • Number of Participants With Death as an Outcome, Serious Adverse Events (SAEs), Treatment-related Adverse Events (AEs), AEs, and Discontinuations Due to AEs [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Abnormal Vital Sign Measurements and Physical Examination Findings [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Abnormal Clinical Laboratory Findings [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) and Observed Plasma Concentration at 12 Hours (C12)and at 24 Hours (C24) [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]), Area Under the Plasma Concentration-time Curve from Time Zero (AUC[INF]) extrapolated to infinite time [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Plasma Half-life (T-half) [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Apparent Total Body Clearance (CLT/F) [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Magnitude and Rate of Change in Plasma Hepatitis C Virus(HCV) RNA Levels From Baseline [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Change in Blood Pressure From Baseline [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Change in Electrocardiogram (ECG) Parameters (Heart Rate, PR, QRS, QT, and QTc Intervals) [ Time Frame: At screening, Day -1, Day 1, Day 3, and Day 7 ] [ Designated as safety issue: No ]
  • Time of Cmax (Tmax) [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: November 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dose Panel A

BMS-790052 - 1 mg

Placebo - 0 mg

Drug: BMS-790052
Oral Solution, Oral, Single Dose
Drug: Placebo
Oral Solution, Oral, Single Dose
Active Comparator: Dose Panel B

BMS-790052 - 10 mg

Placebo - 0 mg

Drug: BMS-790052
Oral Solution, Oral, Single Dose
Drug: Placebo
Oral Solution, Oral, Single Dose
Active Comparator: Dose Panel C

BMS-790052 - 100 mg

Placebo - 0 mg

Drug: BMS-790052
Oral Solution, Oral, Single Dose
Drug: Placebo
Oral Solution, Oral, Single Dose
Active Comparator: Dose Panel D

BMS-790052 - 0.5 - 200 mg (to be determined)

Placebo - 0 mg

Drug: BMS-790052
Oral Solution, Oral, Single Dose
Drug: Placebo
Oral Solution, Oral, Single Dose

  Eligibility

Ages Eligible for Study:   18 Years to 49 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
  • Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
  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: NCT00546715

Locations
United States, California
Advanced Clinical Res Inst
Anaheim, California, United States, 92801
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Maryland
Parexel International Corporation
Baltimore, Maryland, United States, 21225
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
Bristol-Myers Squibb Clinical Pharmacology Unit
Hamilton, New Jersey, United States, 08690
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
University Of Virginia Digestive Health Center Of Excellence
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00546715     History of Changes
Other Study ID Numbers: AI444-002
Study First Received: October 17, 2007
Last Updated: September 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
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 October 19, 2014