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

Phase 1

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00458107
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-09
• Study Completion: 2007-09
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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