Single-Dose Escalation Study of IDX184 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00730431
First received: August 5, 2008
Last updated: December 10, 2008
Last verified: December 2008
  Purpose

The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans.


Condition
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IDX184 After Oral Administration in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Idenix Pharmaceuticals:

Estimated Enrollment: 48
Study Start Date: July 2008
Estimated Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Healthy volunteers, 5mg-100mg IDX184 single dose
2
Healthy volunteers, placebo, single dose

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy volunteers

Criteria

Inclusion Criteria:

  • Subjects are in general good health.
  • Subjects have provided written informed consent form
  • All subjects of childbearing potential must have agreed to use a consistent form of an acceptable double-barrier method of birth control

Exclusion Criteria:

  • Pregnant or breastfeeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730431

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

No publications provided

Responsible Party: John Z. Sullivan-Bólyai, MD, MPH, Idenix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00730431     History of Changes
Other Study ID Numbers: IDX-08C-002
Study First Received: August 5, 2008
Last Updated: December 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Idenix Pharmaceuticals:
Hepatitis C, healthy volunteers

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 April 17, 2014