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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00505973
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: SCA-136 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SCA-136 Administered Orally to Healthy Japanese Male Subjects
Study Start Date : July 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Adverse events, safety laboratory results, vital signs, and ECGs will be used to monitor subject safety.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505973


Locations
Japan
Ikebukuro, Toshima-ku, Japan, 171-0014
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information

ClinicalTrials.gov Identifier: NCT00505973     History of Changes
Other Study ID Numbers: 3153A1-1114
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders