Safety, PK and PD Study in Healthy Male Japanese Subjects - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00447941

Purpose

Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects

Condition	Intervention	Phase
Schizophrenia	Drug: SCA-136	Phase I

MedlinePlus related topics: Schizophrenia

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

Estimated Enrollment:	24
Study Start Date:	June 2006
Estimated Study Completion Date:	September 2006

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447941

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3153A1-103
Study First Received:	March 13, 2007
Last Updated:	March 15, 2007
ClinicalTrials.gov Identifier:	NCT00447941
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Healthy
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009