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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00664625

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 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-791325 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:	May 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Experimental 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
3: Experimental 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
4: Experimental 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664625

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, California
West Coast Clinical Trials, Llc	Recruiting
Cypress, California, United States, 90630
Contact: Apinya Bee Vutikullird, Site 005 714-252-0788
Advanced Clinical Res Inst	Recruiting
Anaheim, California, United States, 92801
Contact: Michael Demicco, Site 006 714-774-7777
United States, Florida
Orlando Clinical Research Center	Suspended
Orlando, Florida, United States, 32809
United States, Maryland
Parexel International Corporation	Suspended
Baltimore, Maryland, United States, 21225
United States, Missouri
Local Institution	Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Site 008
United States, New Jersey
Bristol-Myers Squibb Clinical Pharmacology Unit	Suspended
Hamilton, New Jersey, United States, 08690
United States, Pennsylvania
University Of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Pablo Tebas, Site 009
United States, Texas
Alamo Medical Research	Recruiting
San Antonio, Texas, United States, 78215
Contact: Eric J. Lawitz, Site 007 210-253-3426
United States, Wisconsin
Local Institution	Not yet recruiting
Madison, Wisconsin, United States, 53792
Contact: Site 002
Argentina
Local Institution	Not yet recruiting
Buenos Aires, Argentina, C1181
Contact: Site 011
Argentina, Buenos Aires
Local Institution	Recruiting
Prov. Buenos Aires, Buenos Aires, Argentina, 1629
Contact: Site 010
Local Institution	Recruiting
Vicente Lopez, Buenos Aires, Argentina, 1602
Contact: Site 012

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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:	AI443-002
Study First Received:	April 18, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00664625
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 January 16, 2009