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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-650032
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advanced Clinical Res Inst
  • Orlando Clinical Research Center
  • Parexel International Corporation
  • Central Texas Clinical Research
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BMS-650032

Placebo

Arm Description

Outcomes

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

Secondary Outcome Measures

PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032
Safety Outcome Measures: Safety and tolerability assessments
Pharmacokinetic Measures: Pharmacokinetic assessments

Full Information

First Posted
July 23, 2008
Last Updated
June 15, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00722358
Brief Title
A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-650032
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-650032
Intervention Description
Capsule, Oral, Q12h, 3/5 days Panel 1: 200 mg Panel 2: 400 mg Panel 3: 600 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule, Oral, Q 12h, 3/5 days Panel 1: matching placebo Panel 2: matching placebo Panel 3: matching placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032
Time Frame
28 days after drug
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Res Inst
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Parexel International Corporation
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Local Institution
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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