Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953

A Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI-953 Administered Orally to Healthy Japanese Male Subjects and Healthy Elderly Male Japanese Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00441987

Enrollment

Registered

2007-03-01

Start date

2007-02-28

Completion date

2009-07-31

Last updated

2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Japanese, Healthy, Alzheimers Disease

Brief summary

The purpose of the protocol is to assess the initial pharmacokinetic (PK) profile of a single oral dose of GSI-953 to healthy male Japanese subjects and healthy elderly male Japanese subjects.

Interventions

DRUGGSI-953

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 120 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males aged 20 - 40 and healthy males aged greater than 65. * Body mass index range of 17.6 - 26.4 kg/m2 greater than or equal to 45 kg. * Non-smokers or smoker of fewer than 10 cigarettes a day.

Design outcomes

Primary

Measure	Time frame	Description
Number of participants reporting Adverse Event	10 months	Safety

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026