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CompletedNCT00719394Updated Jul 10, 2009

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

A Phase 1 interventional study of GSI 136 and placebo in Alzheimer Disease and Healthy, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 1 site in Japan. Open to male participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-10.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
20 Years and older
Sex
Male
01

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.

02

Conditions studied

  • Alzheimer Disease
  • Healthy

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Keywords

  • alzheimer Disease
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 72 is close to the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

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Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Men aged 20 to 45 years, or greater than 65 years, inclusive, at screening and who agree to use a medically acceptable form of contraception during the study and to continue its use for 12 weeks after test article administration.
  2. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory tests, vital sign measurements and 12-lead electrocardiogram (ECG).

Exclusion criteria

Exclusion Criteria

  1. Presence or history of any disorder that may prevent the successful completion of the study.
  2. Any history or presence of chronic respiratory disorder or disease including but not limited to asthma, sleep apnea, or chronic obstructive pulmonary disease (COPD).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    GSI 136

    Drug: GSI 136

  • Placebo comparator
    placebo

    Drug: placebo

Interventions

  • DrugGSI 136
  • Drugplacebo
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Tokyo Heat Center
    Tokyo, 141-0001, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00719394
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Jul 21, 2008
Start date
Mar 2008
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Jul 10, 2009

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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