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Safety, PK and PD Study in Healthy Male Japanese Subjects

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Men aged 20 to 45 years at the time of obtaining informed consent.

- Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight ≥ 50 kg.

- Healthy as determined by the investigator on the basis of medical history, physical
examination, clinical laboratory test results, vital signs, and 12-lead
electrocardiogram (ECG).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Presence or history of any disorder that may prevent the successful completion of the
study.

- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

- Any surgical or medical condition that may interfere with the absorption,
distribution, metabolism, or excretion (ADME) of the test article (eg, resection of
liver, kidney, or gastrointestinal tract).

NCT00447941
Pfizer
Completed
Safety, PK and PD Study in Healthy Male Japanese Subjects

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Safety, PK and PD Study in Healthy Male Japanese Subjects
Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sca-136 Administered Orally to Healthy Male Japanese Subjects
Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Schizophrenia
Drug: SCA-136
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
24
August 2006
August 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • Men aged 20 to 45 years at the time of obtaining informed consent.
  • Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight ? 50 kg.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion (ADME) of the test article (eg, resection of liver, kidney, or gastrointestinal tract).
Sexes Eligible for Study: Male
20 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00447941
3153A1-103
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
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

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

Contact

[email protected]



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