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

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.

Completed

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Uppsala, 753 23, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SRA-444

Drug

Primary outcomes

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
To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jul 11, 2007
Registry last updated: Jul 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed