Study GSI-136 in Healthy Young and Healthy Elderly Subjects

NCT00718731 | Completed Phase 1

• 1 other identifier: 3225A1-1000
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Healthy

Keywords

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• 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.

  6 months

Study Arms (2)

1

EXPERIMENTAL

Subject on active drug

Drug: GSI-136

2

PLACEBO COMPARATOR

Subject on placebo

Other: Placebo

Interventions

GSI-136 DRUG

1

Placebo OTHER

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than 50 kg.
• \) 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.

You may not qualify if:

• Any history or presence of chronic respiratory disorder or disease including but not limited to asthma, sleep apnea, or chronic obstructive pulmonary disease (COPD).
• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• Presence or history of thyroid disease, symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris, significant cardiac arrhythmia, or seizures.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 21, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 2, 2010

Record last verified: 2010-04

Locations

US (1)