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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00546715

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 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, Single Group Assignment, Safety Study
Official Title:	Placebo-Controlled Single Ascending Dose Study ot Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-790052 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 ]

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
Dose Panel A: Active Comparator BMS-790052 - 1 mg Placebo - 0 mg	Drug: BMS-790052 Oral Solution, Oral, Single Dose Drug: Placebo Oral Solution, Oral, Single Dose
Dose Panel B: Active Comparator BMS-790052 - 10 mg Placebo - 0 mg	Drug: BMS-790052 Oral Solution, Oral, Single Dose Drug: Placebo Oral Solution, Oral, Single Dose
Dose Panel C: Active Comparator BMS-790052 - 100 mg Placebo - 0 mg	Drug: BMS-790052 Oral Solution, Oral, Single Dose Drug: Placebo Oral Solution, Oral, Single Dose
Dose Panel D: Active Comparator 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

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, 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

More Information

Additional 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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI444-002
Study First Received:	October 17, 2007
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00546715 History of Changes
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
Antiviral Agents
Hepatitis C, Chronic

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases

Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on May 07, 2009