Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese and Non-Japanese Female Subjects
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SCA-136 Administered Orally to Healthy Japanese and Non-Japanese Female Subjects
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 schizophrenia
Started Apr 2007
Shorter than P25 for phase_1 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 5, 2007
CompletedFirst Posted
Study publicly available on registry
April 9, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedDecember 5, 2007
December 1, 2007
April 5, 2007
December 3, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events, safety laboratories results, vital signs, and ECGs will be used to monitor subject safety.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any significant disease.
- Positive urine drug screen, increased liver funtion tests, use of prescription drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Glendale, California, 91206, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 5, 2007
First Posted
April 9, 2007
Study Start
April 1, 2007
Study Completion
September 1, 2007
Last Updated
December 5, 2007
Record last verified: 2007-12