Safety, PK and PD Study in Healthy Male Japanese Subjects

• ClinicalTrials.gov Identifier: NCT00447941
• Recruitment Status: Completed
• First Posted: March 15, 2007
• Last Update Posted: August 7, 2009
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: March 13, 2007
• First Posted Date: March 15, 2007
• Last Update Posted Date: August 7, 2009
• Study Start Date: June 2006
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 14, 2007): safety and tolerability
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00447941 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Schizophrenia
• Intervention: Drug: SCA-136
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: March 14, 2007): 24
• Original Enrollment: Same as current
• Actual Study Completion Date: August 2006
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 20 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00447941
• Other Study ID Numbers: 3153A1-103
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: August 2009