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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00722358

Purpose

The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: BMS-650032 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of BMS-650032 in Subjects Infected With Hepatitis C Virus Genotype 1

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels from baseline. The primary endpoint for antiviral activity is decrease from baseline in plasma HCV RNA levels to Day 3/ or 5 [ Time Frame: To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032 [ Time Frame: 28 days after drug ] [ Designated as safety issue: Yes ]
Safety Outcome Measures: Safety and tolerability assessments [ Time Frame: will be performed for a period of 28 days after administration of multiple doses of BMS-650032 for 3/ or 5 days ] [ Designated as safety issue: Yes ]
Pharmacokinetic Measures: Pharmacokinetic assessments [ Time Frame: will be done on Day 1 for one dosing interval after the AM dose and on Day 3/ or 5 for 72 hours after the last AM dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
BMS-650032: Active Comparator	Drug: BMS-650032 Capsule, Oral, Q12h, 3/5 days Panel 1: 200 mg Panel 2: 400 mg Panel 3: 600 mg
Placebo: Placebo Comparator	Drug: Placebo Capsule, Oral, Q 12h, 3/5 days Panel 1: matching placebo Panel 2: matching placebo Panel 3: matching placebo

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
HCV RNA viral load of ≥10*5 IU/mL
BMI 18 to 35kg/m²

Exclusion Criteria:

Women of childbearing potential (WOCBP)
Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment
HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin
HIV and/or HBV positive
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: NCT00722358

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
Advanced Clinical Res Inst	Recruiting
Anaheim, California, United States, 92801
Contact: Michael Demicco, Site 002
United States, Florida
Orlando Clinical Research Center	Recruiting
Orlando, Florida, United States, 32809
Contact: Thomas C. Marbury, Site 003
United States, Maryland
Parexel International Corporation	Recruiting
Baltimore, Maryland, United States, 21225
Contact: D. Ronald Goldwater, Site 004
United States, Texas
Central Texas Clinical Research	Recruiting
Austin, Texas, United States, 78705
Contact: David Wright, Site 005 512-480-9660
United States, Wisconsin
Local Institution	Not yet recruiting
Madison, Wisconsin, United States, 53792
Contact: Site 006
Puerto Rico
Local Institution	Recruiting
Santurce, Puerto Rico, 00909
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:	AI447-004
Study First Received:	July 23, 2008
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00722358 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 September 11, 2009