Single Ascending Dose Study of SRA-444 in Healthy Subjects

Alzheimer Disease Clinical Trial

Official title:

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRA-444 Administered Orally to Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452504
• Other study ID #: 3197A1-100
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2007
• Last updated: December 3, 2007
• Start date: February 2007
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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) after administration of ascending single oral doses to healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• SRA-444

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the safety and tolerability of SRA-444