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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: SCA-136

Study type: Interventional

Funder types: Industry

Identifiers

NCT00458107

3153A1-1115

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind