Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Evaluate the Effects of Age & Gender on PK, Safety & Tolerability of HCV-796 Administered to Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
ViroPharma
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00407173
First received: November 29, 2006
Last updated: April 10, 2008
Last verified: April 2008
  Purpose

This study is an open-label, single-dose, parallel group study to evaluate the effects of age and gender on the pharmacokinetics, safety, and tolerability of HCV-796 administered orally to healthy subjects.


Condition Intervention Phase
Healthy
Drug: HCV-796
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose, Parallel Group Study to Evaluate the Effects of Age and Gender on the Pharmacokinetics, Safety, and Tolerability of HCV-796 Administered Orally to Healthy Subjects

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

Primary Outcome Measures:
  • To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of a single oral dose of HCV-796 in healthy men and women of different ages. [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: November 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HCV-796 1000mg single dose
Drug: HCV-796
HCV-796 1000mg single dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • Men or nonlactating and nonpregnant women, aged 18 to 45, and >65 years.
  • Men must agree to practice barrier contraception for 12 weeks after the last test article administration.
  • Estimated (calculated) creatinine clearance must be within the age-appropriate normal range.

Exclusion:

  • History of seizures.
  • History of rhabdomyolysis.
  • History of thyroid disease.
  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: NCT00407173

Locations
United States, Florida
Gainesville, Florida, United States, 32608
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
ViroPharma
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00407173     History of Changes
Other Study ID Numbers: 3173A1-112
Study First Received: November 29, 2006
Last Updated: April 10, 2008
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014