A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Subjects - Full Text View

Sponsor:	Idenix Pharmaceuticals
Information provided by:	Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01157104

Purpose

This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy subjects.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: IDX320 and IDX184 Drug: IDX184 and IDX320	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase I, Double-Blind, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX320 and IDX184 in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions Hepatitis Hepatitis A Hepatitis C

U.S. FDA Resources

Further study details as provided by Idenix Pharmaceuticals:

Primary Outcome Measures:

The primary objective is to evaluate PK drug interaction. [ Time Frame: Day 19 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective is to evaluate safety and tolerability. [ Time Frame: Day 19 ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	June 2010
Study Completion Date:	August 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A N=8 IDX320+IDX184 matching placebo for 7 days then for 7 days IDX320+IDX184 N=2 IDX320 matching placebo+IDX184 matching placebo	Drug: IDX320 and IDX184 N=8 Days 1-7 = IDX320 400 mg/d (8x50 mg tablets)+IDX184 matching placebo Days 8-14 = IDX320 400 mg/d+IDX184 100 mg/d (2x50 mg capsules) N=2 Days 1-14 = IDX320 matching placebo+IDX184 matching placebo
Experimental: Group B N=8 IDX184+IDX320 matching placebo for 7 days then IDX184+IDX320 for 7 days N=2 IDX184 matching placebo+IDX320 matching placebo	Drug: IDX184 and IDX320 N=8 Days 1-7 = IDX184 100 mg/d (2x50 mg capsules)+IDX320 matching placebo Days 8-14 = IDX184 100 mg/d+IDX320 400 mg/d (8x50 mg tablets) N=2 Days 1-14 = IDX184 matching placebo+IDX320 matching placebo

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

To participate in the study, subjects must meet the following requirements:

Must be a healthy male or female between 19 and 65 years of age with body mass index (BMI) between 18 and 35 kg/m2.
Must be a non-smoker.
Must agree to use an acceptable double-barrier method of birth control.
Must provide written informed consent after the study has been fully explained.

Exclusion Criteria:

Subjects are not eligible if they meet any of the following:

Pregnant or breastfeeding.
History of clinically significant diseases, as determined by the investigator.
Safety laboratory abnormalities at screening which are clinically significant.
Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.
Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157104

Locations

United States, Nebraska

Lincoln, Nebraska, United States, 68502

Sponsors and Collaborators

Idenix Pharmaceuticals

More Information

No publications provided

Responsible Party:	John Z. Sullivan-Bólyai, MD, MPH/Vice President, Clinical Research, Idenix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01157104 History of Changes
Other Study ID Numbers:	IDX-07A-002
Study First Received:	July 2, 2010
Last Updated:	December 8, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Idenix Pharmaceuticals:

HCV
Hepatitis C

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases

Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on February 09, 2012