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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis C (HCV)

Intervention / Treatment
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* Drug: IDX184


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>Subjects randomized 8:2 (active:placebo) to receive one 25 milligrams (mg) capsule of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. | Drug: IDX184<br>* oral dose, active or placebo<br>|
| Experimental: Cohort B<br>Subjects randomized 8:2 (active:placebo) to receive two 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. | Drug: IDX184<br>* oral dose, active or placebo<br>|
| Experimental: Cohort C<br>Subjects randomized 8:2 (active:placebo) to receive three 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. | Drug: IDX184<br>* oral dose, active or placebo<br>|
| Experimental: Cohort D<br>Subjects randomized 8:2 (active:placebo) to receive four 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. | Drug: IDX184<br>* oral dose, active or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid) | Measures how much virus is in the blood. | Baseline to 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, HCV, treatment-naive