A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects - Full Text View

Purpose

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: BMS-650032 or Placebo	Phase I 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, Safety Study

Official Title:	Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-650032 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1

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 ]

Estimated Enrollment:	24
Study Start Date:	January 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
or Placebo - Dose Panel 1: Experimental Oral Suspension, 10 mg	Drug: BMS-650032 or Placebo Oral, Once daily, Single Dose
or Placebo - Dose Panel 2: Experimental Oral Suspension 50 mg	Drug: BMS-650032 or Placebo Oral, Once daily, Single Dose
or Placebo - Dose Panel 3: Experimental Oral Suspension, 200 mg	Drug: BMS-650032 or Placebo Oral, Once daily, Single Dose
or Placebo - Dose Panel 4: Experimental Oral Suspension or Solution, 2.5 to 600 mg	Drug: BMS-650032 or Placebo 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 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
Co-infection with HIV or HBV
Women of childbearing potential

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559247

Locations


United States, California
	West Coast Clinical Trials, Llc
	Cypress, California, United States, 90630

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, Texas
	Alamo Medical Research
	San Antonio, Texas, United States, 78215

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	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:	AI447-002
First Received:	November 15, 2007
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00559247
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 October 07, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00559247