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

This study has been completed.

First Received: April 5, 2007 Last Updated: December 3, 2007 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00458107

Purpose

This study is being conducted to evaluate the safety and tolerability of ascending multiple oral doses of SCA-136 adminstered to healthy Japanese and non-Japanese female subjects.

Condition	Intervention	Phase
Schizophrenia	Drug: SCA-136	Phase I

MedlinePlus related topics: Schizophrenia

Drug Information available for: SCA136

U.S. FDA Resources

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 and Non-Japanese Female Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Estimated Enrollment:	64
Study Start Date:	April 2007
Study Completion Date:	September 2007

Eligibility

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

Criteria

Inclusion Criteria:

Healthy Japanese women or non-Japanese of child bearing potential using nonhormonal contraceptives.
Japanese female subjects are defined as being born in Japan but living outside of Japan for less than 5 years.

Exclusion Criteria:

Any significant disease.
Positive urine drug screen, increased liver funtion tests, use of prescription drugs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458107

Locations

United States, California

Glendale, California, United States, 91206

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3153A1-1115
Study First Received:	April 5, 2007
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00458107 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Pharmacokinetics
Pharmacodynamics

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 May 07, 2009