Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects

Merck Sharp & Dohme LLC41 enrolled

Overview

This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Hepatitis C (HCV)

Interventions

IDX184DRUG

oral dose, active or placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. 18-65 years old 2. Subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control. 3. Plasma HCV RNA ≥ 5 log10 IU/mL 4. HCV genotype 1 Exclusion criteria: 1. Received prior antiviral treatment for hepatitis C infection 2. Subject is pregnant or breastfeeding 3. Body Mass Index (BMI) \> 32 4. Currently abusing alcohol or illicit drugs 5. Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction 6. Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)

Outcomes

Primary Outcomes

Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events

Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening

Time frame: 17 days

Secondary Outcomes

Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)

Measures how much virus is in the blood.

Time frame: Baseline to 4 days

Data from ClinicalTrials.gov

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