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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Uppsala, , 753 23 Sweden
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00499200
Pfizer
Completed
Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy

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Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
Drug: SRA-444
Experimental: SRA-444 + Placebo
Experimental; Placebo
Intervention: Drug: SRA-444
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
June 2008
June 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00499200
3197A1-1104
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Sweden: [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
July 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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