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Single Ascending Dose Study of SRA-444 in Healthy Subjects

Last updated on November 20, 2019

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Study Location
Zuidlaren, , 9470 AE Netherlands
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00452504
Pfizer
Completed
Single Ascending Dose Study of SRA-444 in Healthy Subjects

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Descriptive Information
Brief Title  ICMJE Single Ascending Dose Study of SRA-444 in Healthy Subjects
Official Title  ICMJE Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRA-444 Administered Orally to Healthy Adult Subjects
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Drug: SRA-444
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 23, 2007)
64
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00452504
Other Study ID Numbers  ICMJE 3197A1-100
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

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 the study website. Please see the references below:

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1-800-718-1021

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