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Completed

NCT Number: NCT00458107

Study Evaluating the Safety and Tolerability of SCA-136 in 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCA-136

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Study completion
2007
First posted
Apr 9, 2007
Registry last updated
Dec 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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