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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00458107

Enrollment

Registered

2007-04-09

Start date

2007-04-30

Completion date

2007-09-30

Last updated

2007-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Pharmacokinetics, Pharmacodynamics

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.

Interventions

DRUGSCA-136

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026