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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 24, 2007

Last Updated Date

December 3, 2007

Start Date ^†

July 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00505973 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SCA-136 Administered Orally to Healthy Japanese Male Subjects

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study

Condition ^†

Schizophrenia

Intervention ^†

Drug: SCA-136

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

October 2007

Primary Completion Date

Eligibility 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.

Gender

Male

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00505973

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Wyeth

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.