Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus

Open Label, Multiple-Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of BMS-824393 in Treatment Naive Subjects Infected With Hepatitis C Virus Genotype 1

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00971308

Enrollment

Registered

2009-09-03

Start date

2009-10-31

Completion date

2010-08-31

Last updated

2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Brief summary

The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.

Interventions

DRUGBMS-824393

Capsule, Oral, 50mg, Once Daily, 3 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1 * HCV RNA viral load of ≤10\*5\* IU/mL (100,000 IU/mL) * Body Mass Index (BMI) of 18 to 35 kg/m², inclusive

Exclusion criteria

* Women who are pregnant or breast feeding * Any significant acute or chronic medical illness which is not stable or is not controlled with medication or is not consistent with Hepatitis C infection * Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study

Design outcomes

Primary

Measure	Time frame
Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects	On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

Secondary

Measure	Time frame
To assess the safety and tolerability of multiple oral doses of BMS-824393	On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
To assess the change in HCV RNA over time during three days of dosing with BMS- 824393 and during the follow-up period in chronically genotype subtype 1a and 1b HCV infected subjects	On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
To assess potential differences in antiviral effect in genotype subtypes (1a versus 1b)	On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026