Study Evaluating Single Doses of GAP-134

Phase 1

Withdrawn

• Conditions: Healthy Subjects
• Interventions: Drug: active; Drug: placebo

• Registration Number: NCT00820521
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to assess the safety and tolerability of ascending single oral doses of GAP-134 in healthy subjects, to provide the initial pharmacokinetic profile of the oral formulation of GAP-134 in healthy subjects, and to evaluate the effect on the pharmacokinetic profile of a high-fat meal of 450 mg of GAP-134 administered to healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Study Start: 2009-02
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
active	active	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability will be evaluated from reported AEs, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECGs, and clinical laboratory test results.	2 months

Secondary Outcome Measures

Name	Time	Method
pharmacokinetic parameters	2 months