Back to resultsSafety, PK and PD Study in Healthy Male Japanese Subjects
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SCA-136
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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).
Sites / Locations
Outcomes
Primary Outcome Measures
safety and tolerability
Secondary Outcome Measures
Full Information
NCT ID
NCT00447941
First Posted
March 13, 2007
Last Updated
August 6, 2009
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00447941
Brief Title
Safety, PK and PD Study in Healthy Male Japanese Subjects
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SCA-136
Primary Outcome Measure Information:
Title
safety and tolerability
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
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
12. IPD Sharing Statement
Learn more about this trial
Safety, PK and PD Study in Healthy Male Japanese Subjects
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