Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: SRA-444	Phase I

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease

ChemIDplus related topics:

Serotonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study

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

Further study details as provided by Wyeth:

Primary Outcome Measures:

To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease [ Time Frame: after each dose group completion ] [ Designated as safety issue: Yes ]
To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	October 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SRA-444 + Placebo: Experimental Experimental; Placebo	Drug: SRA-444

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499200

Locations


Sweden

	Uppsala, Sweden, 753 23

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

Principal Investigator:	Trial Manager	For Sweden: MedInfoNord@wyeth.com

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3197A1-1104
First Received:	July 9, 2007
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00499200
Health Authority:	Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board; United States: Food and Drug Administration