search
Back to results

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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-650032 or 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 or treatment non-responders or treatment intolerant
  • 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
  • Co-infection with HIV or HBV
  • Women of childbearing potential

Sites / Locations

  • West Coast Clinical Trials, Llc
  • Orlando Clinical Research Center
  • Parexel International Corporation
  • Mayo Clinic
  • Alamo Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

or Placebo - Dose Panel 1

or Placebo - Dose Panel 2

or Placebo - Dose Panel 3

or Placebo - Dose Panel 4

Arm Description

Oral Suspension, 10 mg

Oral Suspension 50 mg

Oral Suspension, 200 mg

Oral Suspension or Solution, 2.5 to 600 mg

Outcomes

Primary Outcome Measures

Safety Outcome Measures

Secondary Outcome Measures

Pharmacokinetic Measures
Pharmacodynamic Measures

Full Information

First Posted
November 15, 2007
Last Updated
September 10, 2010
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT00559247
Brief Title
A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects
Official Title
Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-650032 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (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 evaluate the safety profile and tolerability of single oral doses of BMS-650032 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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
or Placebo - Dose Panel 1
Arm Type
Experimental
Arm Description
Oral Suspension, 10 mg
Arm Title
or Placebo - Dose Panel 2
Arm Type
Experimental
Arm Description
Oral Suspension 50 mg
Arm Title
or Placebo - Dose Panel 3
Arm Type
Experimental
Arm Description
Oral Suspension, 200 mg
Arm Title
or Placebo - Dose Panel 4
Arm Type
Experimental
Arm Description
Oral Suspension or Solution, 2.5 to 600 mg
Intervention Type
Drug
Intervention Name(s)
BMS-650032 or Placebo
Intervention Description
Oral, Once daily, Single Dose
Primary Outcome Measure Information:
Title
Safety Outcome Measures
Time Frame
Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose
Secondary Outcome Measure Information:
Title
Pharmacokinetic Measures
Time Frame
Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose
Title
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

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 or treatment non-responders or treatment intolerant 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 Co-infection with HIV or HBV Women of childbearing potential
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
West Coast Clinical Trials, Llc
City
Cypress
State/Province
California
ZIP/Postal Code
90630
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
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs