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Study GSI-136 in Healthy Young and Healthy Elderly Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00718731
First received: July 17, 2008
Last updated: April 1, 2010
Last verified: April 2010

July 17, 2008
April 1, 2010
March 2008
August 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00718731 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study GSI-136 in Healthy Young and Healthy Elderly Subjects
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI 136 Administered Orally to Healthy Young and Healthy Elderly Subjects

This 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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Healthy
  • Drug: GSI-136
  • Other: Placebo
  • Experimental: 1
    Subject on active drug
    Intervention: Drug: GSI-136
  • Placebo Comparator: 2
    Subject on placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
August 2008
August 2008   (final data collection date for primary outcome measure)

<Inclusion:

  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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00718731
3225A1-1000
No
Director, Clinical Trial Disclosure Group, Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP