Study Evaluating the Pharmacokinetics of HCV-796 in Healthy Japanese Men

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00385190
First received: October 3, 2006
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

The purpose of the study is to assess the safety and tolerability of ascending multiple oral doses of HCV-796 in healthy Japanese male subjects.


Condition Intervention Phase
Healthy
Drug: HCV-796
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of Study Drug Administred Orally to Healthy Japanese Male Subjects

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety and pharmacokinetics

Estimated Enrollment: 24
Study Start Date: July 2006
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.
  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: NCT00385190

Locations
Japan
Minato-ku, Tokyo, Japan, 108-8642
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00385190     History of Changes
Other Study ID Numbers: 3173A1-108
Study First Received: October 3, 2006
Last Updated: August 17, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
SAD

ClinicalTrials.gov processed this record on October 16, 2014