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

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ClinicalTrials.gov Identifier: NCT00407173
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : April 14, 2008
Sponsor:
Collaborator:
ViroPharma
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: HCV-796 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Arm Intervention/treatment
Experimental: 1
HCV-796 1000mg single dose
Drug: HCV-796
HCV-796 1000mg single dose




Primary Outcome Measures :
  1. To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00407173     History of Changes
Other Study ID Numbers: 3173A1-112
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: April 14, 2008
Last Verified: April 2008