Back to resultsSingle Ascending Dose Study of SRA-444 in Healthy Subjects
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
SRA-444
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
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).
Sites / Locations
Outcomes
Primary Outcome Measures
Assessment of the safety and tolerability of SRA-444
Secondary Outcome Measures
Full Information
NCT ID
NCT00452504
First Posted
March 23, 2007
Last Updated
December 3, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00452504
Brief Title
Single Ascending Dose Study of SRA-444 in Healthy Subjects
Official Title
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRA-444 Administered Orally to Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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) after administration of ascending single oral doses to healthy adult subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SRA-444
Primary Outcome Measure Information:
Title
Assessment of the safety and tolerability of SRA-444
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Netherlands, trials-NL@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Zuidlaren
ZIP/Postal Code
9470 AE
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Single Ascending Dose Study of SRA-444 in Healthy Subjects
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