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

Phase 1

Completed

• Conditions: Arrhythmia
• Interventions: Drug: GAP-134

• Registration Number: NCT00510029
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The study will assess the safety, tolerability and pharmacokinetics of single intravenous (IV) doses of GAP-134 in healthy subjects. GAP-134 will be administered as a 24-hour infusion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-31
• Study First Submitted QC: 2007-07-31
• Study First Posted: 2007-08-01
• Study Start: 2007-09
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-12
• Last Update Posted: 2008-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GAP-134, IV and Oral	GAP-134	Experimental; Active Comparator; Placebo

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of single ascending IV doses of GAP-134 administered as 24-hour continuous infusions and as single bolus injection of GAP-134 in healthy subjects	3-4 months

Secondary Outcome Measures

Name	Time	Method
To provide the initial Pharmacokinetic (PK) profile of single ascending IV doses (24 hour and 1-minute) and the initial PK assessment of the bioavailability of an oral formulation of GAP-134 under fasting conditions in healthy subjects	3-4 months