Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: GAP-134; Drug: placebo

• Registration Number: NCT00783341
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of GAP 134 administered as 6-day continuous IV infusions to healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Study Start: 2008-11
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-16
• Last Update Posted: 2009-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GAP-134	GAP-134	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Safety as determined by reported adverse events, laboratory test results, and ECGs	3 weeks

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters	9 days