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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Hepatitis C (HCV)

Treatments: Drug: IDX184

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807001

IDX-08C-003

2355-003

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 4 patient groups

Cohort A

Experimental group

Description:

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.

Treatment:

Drug: IDX184

Cohort B

Experimental group

Description:

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.

Treatment:

Drug: IDX184

Cohort C

Experimental group

Description:

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.

Treatment:

Drug: IDX184

Cohort D

Experimental group

Description:

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.

Treatment:

Drug: IDX184