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

Primary Purpose

Chronic Hepatitis C

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BMS-791325

Placebo

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 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

Sites / Locations

Advanced Clinical Res Inst
West Coast Clinical Trials, Llc
Washington University School Of Medicine
University Of Pennsylvania
Alamo Medical Research
Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

BMS-791325 (100 mg) or placebo match for (100 mg)

BMS-791325 (300 mg) or placebo match for (300 mg)

BMS-791325 (900 mg) or placebo match for (900 mg)

BMS-791325 (potential dose between 10-800 mg) or placebo match for (10-800 mg)

Outcomes

Primary Outcome Measures

Safety Outcome Measures

Secondary Outcome Measures

Pharmacokinetic Measures

Pharmacodynamic Measures

Full Information

NCT ID

NCT00664625

First Posted

April 18, 2008

Last Updated

September 23, 2015

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00664625

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

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-791325 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 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

BMS-791325 (100 mg) or placebo match for (100 mg)

Arm Title

Arm Type

Experimental

Arm Description

BMS-791325 (300 mg) or placebo match for (300 mg)

Arm Title

Arm Type

Experimental

Arm Description

BMS-791325 (900 mg) or placebo match for (900 mg)

Arm Title

Arm Type

Experimental

Arm Description

BMS-791325 (potential dose between 10-800 mg) or placebo match for (10-800 mg)

Intervention Type

Drug

Intervention Name(s)

BMS-791325

Intervention Description

Capsules, Oral, Once Daily, Single Dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsules, 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

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 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

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

West Coast Clinical Trials, Llc

City

Cypress

State/Province

California

ZIP/Postal Code

90630

Country

United States

Facility Name

Washington University School Of Medicine

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

University Of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Alamo Medical Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1181

Country

Argentina

12. IPD Sharing Statement

Citations:

PubMed Identifier

24733462

Citation

Sims KD, Lemm J, Eley T, Liu M, Berglind A, Sherman D, Lawitz E, Vutikullird AB, Tebas P, Gao M, Pasquinelli C, Grasela DM. Randomized, placebo-controlled, single-ascending-dose study of BMS-791325, a hepatitis C virus (HCV) NS5B polymerase inhibitor, in HCV genotype 1 infection. Antimicrob Agents Chemother. 2014 Jun;58(6):3496-503. doi: 10.1128/AAC.02579-13. Epub 2014 Apr 14.

Results Reference

derived

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

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