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

This study has been completed.
Sponsor:
Information provided by:
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01157104
First received: July 2, 2010
Last updated: December 8, 2010
Last verified: December 2010
  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 1

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:


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:

  1. 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.
  2. Must be a non-smoker.
  3. Must agree to use an acceptable double-barrier method of birth control.
  4. 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:

  1. Pregnant or breastfeeding.
  2. History of clinically significant diseases, as determined by the investigator.
  3. Safety laboratory abnormalities at screening which are clinically significant.
  4. Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
  5. 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.
  6. Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on October 01, 2014