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

NCT ID: NCT00807001

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-07-31

Brief Summary

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.

Conditions

Chronic Hepatitis C (HCV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort A

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.

Group Type: EXPERIMENTAL

IDX184

Intervention Type: DRUG

oral dose, active or placebo

Cohort B

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.

Group Type: EXPERIMENTAL

IDX184

Intervention Type: DRUG

oral dose, active or placebo

Cohort C

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.

Group Type: EXPERIMENTAL

IDX184

Intervention Type: DRUG

oral dose, active or placebo

Cohort D

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.

Group Type: EXPERIMENTAL

IDX184

Intervention Type: DRUG

oral dose, active or placebo

Interventions

IDX184

oral dose, active or placebo

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Lalezari J, Asmuth D, Casiro A, Vargas H, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. Short-term monotherapy with IDX184, a liver-targeted nucleotide polymerase inhibitor, in patients with chronic hepatitis C virus infection. Antimicrob Agents Chemother. 2012 Dec;56(12):6372-8. doi: 10.1128/AAC.01521-12. Epub 2012 Oct 15.

Reference Type: RESULT

PMID: 23070151 (View on PubMed)

Other Identifiers

IDX-08C-003

Identifier Type: -

Identifier Source: secondary_id

2355-003

Identifier Type: -

Identifier Source: org_study_id