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Study Evaluating Safety of GSI 136 in Young and Elderly Japanese Males

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Tokyo Heat Center
Tokyo, , 141-0001 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease, Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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).

NCT00719394
Pfizer
Completed
Study Evaluating Safety of GSI 136 in Young and Elderly Japanese Males

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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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Healthy
  • Drug: GSI 136
  • Drug: placebo
  • Experimental: GSI 136
    Intervention: Drug: GSI 136
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
August 2008
August 2008   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Male
20 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00719394
3225A1-1001
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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