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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCV-796

• Registration Number: NCT00407173
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-30
• Study First Posted: 2006-12-04
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-10
• Last Update Posted: 2008-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	HCV-796	HCV-796 1000mg single dose

Primary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages.	7 days

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of a single oral dose of HCV-796 in healthy men and women of different ages.	15 days