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

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.

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Key information

Conditions

Chronic Hepatitis C (HCV) Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18-65 years old
Subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control.
Plasma HCV RNA ≥ 5 log10 IU/mL
HCV genotype 1

Exclusion criteria

Received prior antiviral treatment for hepatitis C infection
Subject is pregnant or breastfeeding
Body Mass Index (BMI) > 32
Currently abusing alcohol or illicit drugs
Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction
Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)

Treatment and study plan

IDX184

Drug

oral dose, active or placebo

Primary outcomes

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

Time frame: 17 days

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

Secondary outcomes

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

Time frame: Baseline to 4 days

Measures how much virus is in the blood.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected With Genotype 1 Chronic Hepatitis C

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Dec 11, 2008
Registry last updated: Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed