drugset / Trial / NCT03370640

Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2).

NCT03370640

Phase 1 Completed 24 enrolled Sumitomo Pharma Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a multiple oral dose, open-label study to assess the safety, tolerability, and pharmacokinetics of SEP-363856 in Japanese subjects with schizophrenia.

Timeline

Start
2017-11-29
Primary completion
2018-09-20
Completion
2018-09-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulotaront Small molecule 50 mg Oral
Subject Ulotaront Small molecule 75 mg Oral

Indications