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, Missouri
Washington University School Of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Mauricio Lisker-Melman, Site 008 314-362-8940
United States, Pennsylvania
University Of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Pablo Tebas, Site 009 215-349-8091
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	Recruiting
Buenos Aires, Argentina, C1181
Contact: Site 011
Argentina, Buenos Aires
Local Institution	Recruiting
Prov. Buenos Aires, Buenos Aires, Argentina, 1629
Contact: Site 010

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