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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505973
• Other study ID #: 3153A1-1114
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2007
• Last updated: December 3, 2007
• Start date: July 2007
• Est. completion date: October 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SCA-136

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, safety laboratory results, vital signs, and ECGs will be used to monitor subject safety.