NCT00719394

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

Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI-136 Administered Orally to Healthy Japanese Male Subjects and Healthy Japanese Elderly Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer Disease
• Healthy

Interventions

Type	Name	Description
DRUG	GSI 136
DRUG	placebo

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-07-21
• Last updated: 2009-07-10

Locations

1 site across 1 country: Japan