Study Evaluating Safety of GSI 136 in Young and Elderly Japanese Males

Phase 1

Completed

• Conditions: Alzheimer Disease; Healthy
• Interventions: Drug: placebo; Drug: GSI 136

• Registration Number: NCT00719394
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

This is a first-in-human study of GSI-136, a gamma-secretase inhibitor being developed for the treatment of Alzheimer disease. This study will take place in Japan only and will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GSI-136 after administration of ascending single oral doses to healthy Japanese male subjects and healthy Japanese elderly male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-08
• Last Update Posted: 2009-07-10

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
GSI 136	GSI 136	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of GSI-136 as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, orthostatic vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results.	6 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics as evaluated from the blood and urine concentrations of GSI-136; Pharmacodynamics as evaluated from the levels of select biomarkers in the blood and the administration of a visual analog scale to measure sedation effects.	6 months

Trial Locations

Locations (1)

Tokyo Heat Center; 🇯🇵 Tokyo, Japan