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CompletedPhase 1

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

Asset

GSI 136

Listed sites

1

Recruiting sites

-

Enrollment

72

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Age ≥20•Male

Primary endpoint

•Safety and tolerability of GSI-136 as evaluated from reported adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID3225A1-1001
NCT IDNCT00719394

Timeline

Milestones

Study start2008-03 (month precision)
Study first posted2008-07-21estimated
Primary completion2008-08actual (month precision)
Study completion2008-08actual (month precision)
Last update posted2009-07-10estimated

Assets

Drug assets

GSI 136

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age20 Years
SexMale
Healthy volunteersAccepted

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).

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

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

event count, event

Secondary/protocol endpoint

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

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.