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Study GSI-136 in Healthy Young and Healthy Elderly Subjects

Last updated on November 8, 2019

FOR MORE INFORMATION
Study Location
New York, New York, 10019 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease, Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00718731
Pfizer
Completed
Study GSI-136 in Healthy Young and Healthy Elderly Subjects

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Descriptive Information
Brief Title  ICMJE Study GSI-136 in Healthy Young and Healthy Elderly Subjects
Official Title  ICMJE Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI 136 Administered Orally to Healthy Young and Healthy Elderly Subjects
Brief SummaryThis is a first-in-humans study of GSI-136, a drug being developed for the treatment of Alzheimer Disease. The main purpose of this study is to determine whether GSI-136 is safe and tolerable in healthy young and healthy elderly subjects. The amount of drug in the body and the effects of the drug on the body will also be evaluated at certain timepoints.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer Disease
  • Healthy
Intervention  ICMJE
  • Drug: GSI-136
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: 1
    Subject on active drug
    Intervention: Drug: GSI-136
  • Placebo Comparator: 2
    Subject on placebo
    Intervention: Other: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 18, 2008)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion DateAugust 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

  1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years or greater than 65 years, inclusive, at screening. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than 1 year (with follicle-stimulating hormone [FSH] level greater than 38 mIU/mL) and must have a negative pregnancy test result within 48 hours before test article administration. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
  2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than 50 kg.

3) The elderly subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. Subjects may be included with clinically important deviations from normal limits in medical history, physical examination findings, vital sign measurements, 12-lead ECGs, or clinical laboratory test results that are associated with stable, chronic, and well-controlled medical conditions.

Exclusion:

  1. Any history or presence of chronic respiratory disorder or disease including but not limited to asthma, sleep apnea, or chronic obstructive pulmonary disease (COPD).
  2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  3. Presence or history of thyroid disease, symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris, significant cardiac arrhythmia, or seizures.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00718731
Other Study ID Numbers  ICMJE 3225A1-1000
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateApril 2010

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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