Status:
COMPLETED
Safety, PK and PD Study in Healthy Male Japanese Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Schizophrenia
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00447941
Start Date
June 1 2006
End Date
August 1 2006
Last Update
August 7 2009
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