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A Open-label Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01335607
First received: April 8, 2011
Last updated: July 11, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to:

  • Compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting.
  • Determine the amount of study drug that is in the blood after eating a meal.
  • Evaluate the safety of the tablet form of IDX184 in healthy people.

Condition Intervention Phase
Hepatitis C
 Drug: IDX184
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase I, Open-label Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Idenix Pharmaceuticals:

Primary Outcome Measures:
  • Relative bioavailability [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters, including area under the concentration-time curve (AUC) and maximum observed concentration (Cmax) of IDX184 and 2'-MeG, following oral administration of the capsule and tablet forms of IDX184.

  • Blood levels of study drug measured in each study participant. [ Time Frame: 6 Days ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters, including AUC and Cmax of IDX184 and 2'-MeG, following oral administration of a tablet form of IDX184 with and without food.


Secondary Outcome Measures:
  • Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events [ Time Frame: 20 Days ] [ Designated as safety issue: No ]
    Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms.


Enrollment: 12
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A Drug: IDX184
  • Day 1: 2x50 mg IDX184 capsules without food
  • Day 8: 2x50 mg IDX184 tablets without food
  • Day 15:2x50 mg IDX184 tablets with food
Active Comparator: Group B Drug: IDX184
  • Day 1: 2x50 mg IDX184 tablets without food;
  • Day 8: 2x50 mg IDX184 capsules without food;
  • Day 15: 2x50 mg IDX184 tablets with food;

  Eligibility

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

Inclusion Criteria:

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

  1. Must be a healthy male between 19 and 65 years of age with body mass index (BMI) between 18 and 35 kg/m(2).
  2. Must agree to use an acceptable double-barrier method of birth control.
  3. 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. History of clinically significant diseases, as determined by the investigator.
  2. Safety laboratory abnormalities at screening which are clinically significant.
  3. Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
  4. 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.
  5. 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: NCT01335607

Locations
United States, Nebraska
Lincoln, Nebraska, United States
Sponsors and Collaborators
Idenix Pharmaceuticals
  More Information

No publications provided

Responsible Party: John Sullivan-Bolyai/VP Clinical Research, Idenix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01335607     History of Changes
Other Study ID Numbers: IDX-08C-006
Study First Received: April 8, 2011
Last Updated: July 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Idenix Pharmaceuticals:
HCV
Hepatitis C Virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
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 May 16, 2013