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

NCT00719394 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2009-07-10

No results posted yet for this study

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

DRUG

GSI 136

DRUG

placebo

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00719394 on ClinicalTrials.gov