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
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 alzheimer-disease
Started Mar 2008
Shorter than P25 for phase_1 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 17, 2008
CompletedFirst Posted
Study publicly available on registry
July 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJuly 10, 2009
July 1, 2009
5 months
July 17, 2008
July 8, 2009
Conditions
Keywords
Outcome Measures
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.
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.
6 months
Study Arms (2)
GSI 136
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
- 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).
You may not qualify if:
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any history or presence of chronic respiratory disorder or disease including but not limited to asthma, sleep apnea, or chronic obstructive pulmonary disease (COPD).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tokyo Heat Center
Tokyo, 141-0001, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 17, 2008
First Posted
July 21, 2008
Study Start
March 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
July 10, 2009
Record last verified: 2009-07