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

Chronic Hepatitis C (HCV) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807001
• Other study ID #: 2355-003
• Secondary ID: IDX-08C-003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 10, 2008
• Last updated: August 18, 2016
• Start date: December 2008
• Est. completion date: July 2009

Study information

• Verified date: August 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Ministry of HealthEuropean Union: National Health Authorities.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C (HCV)
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• IDX184
oral dose, active or placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Lalezari J, Asmuth D, Casiró A, Vargas H, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bólyai J, Mayers D. Short-term monotherapy with IDX184, a liver-targeted nucleotide polymerase inhibitor, in patients with chroni — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No