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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-09-30

Brief Summary

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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

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Conditions

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Schizophrenia

Keywords

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Pharmacokinetics Pharmacodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SCA-136

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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3153A1-1115

Identifier Type: -

Identifier Source: org_study_id