NCT00664625

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2008

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

October 9, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

April 18, 2008

Last Update Submit

September 23, 2015

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Safety Outcome Measures

    Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose

Secondary Outcomes (2)

  • Pharmacokinetic Measures

    Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose

  • Pharmacodynamic Measures

    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

Study Arms (4)

1

EXPERIMENTAL

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

Drug: BMS-791325Drug: Placebo

2

EXPERIMENTAL

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

Drug: BMS-791325Drug: Placebo

3

EXPERIMENTAL

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

Drug: BMS-791325Drug: Placebo

4

EXPERIMENTAL

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

Drug: BMS-791325Drug: Placebo

Interventions

BMS-791325DRUG

Capsules, Oral, Once Daily, Single Dose

1234
PlaceboDRUG

Capsules, Oral, Once Daily, Single Dose

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Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Advanced Clinical Res Inst

Anaheim, California, 92801, United States

Location

West Coast Clinical Trials, Llc

Cypress, California, 90630, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Local Institution

Buenos Aires, Buenos Aires, C1181, Argentina

Location

Related Publications (1)

  • 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.

    PMID: 24733462DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 23, 2008

Study Start

May 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 9, 2015

Record last verified: 2015-09

Locations

US(5)AR(1)