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Single-Dose Escalation Study of IDX184 in Healthy Volunteers

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: August 5, 2008
Last updated: December 10, 2008
Last verified: December 2008

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

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 Merck Sharp & Dohme Corp.:

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)
Healthy volunteers, 5mg-100mg IDX184 single dose
Healthy volunteers, placebo, single dose


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


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 identifier: NCT00730431

United States, Nebraska
Lincoln, Nebraska, United States
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: John Z. Sullivan-Bólyai, MD, MPH, Idenix Pharmaceuticals, Inc. 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 Merck Sharp & Dohme Corp.:
Hepatitis C, healthy volunteers

Additional relevant MeSH terms:
Hepatitis C
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases processed this record on November 25, 2014