Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy

Alzheimer's Disease Clinical Trial

Official title:

A Positron Emission Tomography Study to Assess the Level and Duration of Occupancy of Serotonin-1A Receptors Produced by Single Oral Doses of SRA-444 in Healthy Elderly Subjects and in Subjects With Alzheimer Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499200
• Other study ID #: 3197A1-1104
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2007
• Last updated: July 7, 2008
• Start date: October 2007
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study will include a preliminary pharmacokinetics (PK) / safety / tolerability evaluation in healthy elderly subjects followed by the Receptor Occupancy (RO) evaluations in healthy elderly subjects and in Alzheimer's Disease (AD) subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion criteria:

• Men or women from 60 years of age at screening.

• Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion criteria:

• History of drug abuse within 1 year before study day 1.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• SRA-444

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease		after each dose group completion	Yes
Primary	To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET		1 month	No