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
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: 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 August 26, 2014