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

Bristol-Myers Squibb37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

BMS-824393DRUG

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

BMS-824393DRUG

Capsule, Oral, 100mg, Once Daily, 3 days

BMS-824393DRUG

Capsule, Oral, 10mg, Once Daily, 3 days

BMS-824393

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (6)

Advanced Clinical Research Institute

Anaheim, California, United States

West Coast Clinical Trials, Llc

Cypress, California, United States

Elite Research Institute

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Outcomes

Primary Outcomes

Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects

Time frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

Secondary Outcomes

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

Time frame: 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)

Time frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

To assess the safety and tolerability of multiple oral doses of BMS-824393

Time frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

Data from ClinicalTrials.gov

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