drugset / Trial / NCT03436849

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects

NCT03436849

Phase 1 Completed 44 enrolled Astellas Pharma Inc
RandomizedSequentialTriple-blindBasic science

Summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple oral doses of ESN364 in healthy Japanese male and pre- and post-menopausal female subjects. This study will also evaluate the pharmacokinetics (PK) of ESN364 and its metabolite, and the pharmacodynamics (PD) of ESN364 after single and multiple oral doses administration in healthy Japanese male and pre- and post-menopausal female subjects.

Timeline

Start
2018-02-22
Primary completion
2018-05-23
Completion
2018-05-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Fezolinetant Small molecule Oral

Indications

No indication recorded.