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

Sponsored by:	Idenix Pharmaceuticals
Information provided by:	Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00807001

Purpose

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 in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: IDX184	Phase I Phase II

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Idenix Pharmaceuticals:

Primary Outcome Measures:

Safety and tolerability. Monitoring of adverse events, physical examinations, routine safety laboratory parameters and electrocardiograms. [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Antiviral activity. Change in plasma RNA [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort A: Experimental Subjects randomized 8:2 (active:placebo) to receive IDX184 25 mg	Drug: IDX184 oral dose, active or placebo
Cohort B: Experimental Subjects randomized 8:2 (active:placebo) to receive IDX184 50 mg	Drug: IDX184 oral dose, active or placebo
Cohort C: Experimental Subjects randomized 8:2 (active:placebo) to receive IDX184 75 mg	Drug: IDX184 oral dose, active or placebo
Cohort D: Experimental Subjects randomized 8:2 (active:placebo) to receive IDX184 100 mg	Drug: IDX184 oral dose, active or placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807001

Contacts

Contact: John Z. Sullivan-Bolyai, MD, MPH

877-433-6491

Show 25 Study Locations

Sponsors and Collaborators

Idenix Pharmaceuticals

More Information

Responsible Party:	Idenix Pharmaceuticals, Inc. ( John Z. Sullivan-Bolyai, MD, MPH )
Study ID Numbers:	IDX-08C-003
Study First Received:	December 10, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00807001
Health Authority:	United States: Food and Drug Administration; Argentina: Ministry of Health; European Union: National Health Authorities.

Keywords provided by Idenix Pharmaceuticals:

Hepatitis C, treatment-naive

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009