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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Alzheimer Disease
• Intervention / Treatment: Drug: placebo; Drug: GSI 136

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 141-0001
    • Tokyo Heat Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: placebo
EXPERIMENTAL: GSI 136	Drug: GSI 136

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): August 1, 2008
• Study Completion (ACTUAL): August 1, 2008

Study Registration Dates

• First Submitted: July 17, 2008
• First Submitted That Met QC Criteria: July 18, 2008
• First Posted (ESTIMATE): July 21, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 10, 2009
• Last Update Submitted That Met QC Criteria: July 8, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: alzheimer Disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 3225A1-1001