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

September 23, 2015 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181
        • Local Institution
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Res Inst
      • Cypress, California, United States, 90630
        • West Coast Clinical Trials, Llc
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1

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
Experimental: 2

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
Experimental: 3

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
Experimental: 4

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Outcome Measures
Time Frame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose
Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic Measures
Time Frame: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose
Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI443-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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