Clinical trial NCT00718731: Study GSI-136 in Healthy Young and Healthy Elderly Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI 136 Administered Orally to Healthy Young and Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Healthy
Keywords: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: \<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.

Primary outcomes:
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.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
state: New York
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: