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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSI 136 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSI 136 | Drug |
| ||
| placebo |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria .
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Heat Center | Tokyo | 141-0001 | Japan |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |