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Single Ascending Dose Study of SRA-444 in Healthy Subjects

Last updated on May 10, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Single Ascending Dose Study of SRA-444 in Healthy Subjects
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRA-444 Administered Orally to Healthy Adult Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Alzheimer Disease
Drug: SRA-444
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
June 2007
Not Provided

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).
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00452504
3197A1-100
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Netherlands, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
December 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]



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