Back to resultsStudy Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese and Non-Japanese Female Subjects
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SCA-136
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Pharmacokinetics, Pharmacodynamics
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Adverse events, safety laboratories results, vital signs, and ECGs will be used to monitor subject safety.
Secondary Outcome Measures
Full Information
NCT ID
NCT00458107
First Posted
April 5, 2007
Last Updated
December 3, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00458107
Brief Title
Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese and Non-Japanese Female Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Pharmacokinetics, Pharmacodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SCA-136
Primary Outcome Measure Information:
Title
Adverse events, safety laboratories results, vital signs, and ECGs will be used to monitor subject safety.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese and Non-Japanese Female Subjects
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