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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00719394
First received: July 17, 2008
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Healthy
Drug: GSI 136
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSI 136 Drug: GSI 136
Placebo Comparator: placebo Drug: placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719394

Locations
Japan
Tokyo Heat Center
Tokyo, Japan, 141-0001
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00719394     History of Changes
Other Study ID Numbers: 3225A1-1001
Study First Received: July 17, 2008
Last Updated: July 8, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
alzheimer Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 23, 2014