Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese Male Subjects

This study has been completed.

First Received: July 24, 2007 Last Updated: December 3, 2007 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00505973

Purpose

This study is being conducted to assess the safety and tolerability of ascending multiple oral doses of SCA-136 administered to healthy Japanese male subjects.

Condition	Intervention	Phase
Schizophrenia	Drug: SCA-136	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title:	An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SCA-136 Administered Orally to Healthy Japanese Male Subjects

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: SCA136

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Adverse events, safety laboratory results, vital signs, and ECGs will be used to monitor subject safety.

Estimated Enrollment:	24
Study Start Date:	July 2007
Study Completion Date:	October 2007

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Healty Japanese men willing to use a medically acceptable form of contraception.

Exclusion criteria:

Any significant disease
Positive urine drug screen
Increased liver function tests
Use of prescription drugs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505973

Locations

Japan, Toshima-ku

Ikebukuro, Toshima-ku, Japan, 171-0014

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3153A1-1114
Study First Received:	July 24, 2007
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00505973 History of Changes
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

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 11, 2009