Status:
COMPLETED
Single Ascending Dose Study of SRA-444 in Healthy Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Alzheimer Disease
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
This is a first-in-humans study of SRA-444. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRA-444 (SR formulation) afte...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00452504
Start Date
February 1 2007
End Date
June 1 2007
Last Update
December 5 2007
Active Locations (1)
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1
Zuidlaren, Netherlands, 9470 AE