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

December 3, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events, safety laboratories results, vital signs, and ECGs will be used to monitor subject safety.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

April 5, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (Estimate)

April 9, 2007

Study Record Updates

Last Update Posted (Estimate)

December 5, 2007

Last Update Submitted That Met QC Criteria

December 3, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3153A1-1115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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