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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00452504 |
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Date of registration:
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23/03/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Single Ascending Dose Study of SRA-444 in Healthy Subjects
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Scientific title:
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Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRA-444 Administered Orally to Healthy Adult Subjects |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00452504 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Netherlands, trials-NL@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Healthy men or women of nonchildbearing potential aged 18 to 50 years,
- Body mass index in the range of 18 to 30 kg/m2 and body weight =50 kg.
Exclusion criteria:
- Family history of sudden death and/or QT prolongation.
- An automatic ECG corrected QT (QTc) interval reading at screening >450 ms and >470 ms
for male and female subjects, respectively.
- Sinus bradycardia at screening, defined as a resting heart rate =45 bpm. Resting
supine blood pressure at screening <110 mm Hg (systolic) and/or <60 mm Hg
(diastolic).
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Alzheimer Disease
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Intervention(s)
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Drug: SRA-444
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Primary Outcome(s)
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Assessment of the safety and tolerability of SRA-444
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Secondary ID(s)
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3197A1-100
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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