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.
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Safety assessed by incidence of adverse events (AEs) in Part 1
Timeframe: Up to Day 12 in Part 1
Safety assessed by incidence of AEs in Part 2
Timeframe: Up to Day 24 in Part 2
Safety assessed by vital signs: Body temperature in Part 1
Timeframe: Up to day 12 in Part 1
Safety assessed by vital signs: Body temperature in Part 2
Timeframe: Up to Day 24 in Part 2
Safety assessed by vital signs: Blood pressure in Part 1
Timeframe: Up to Day 12 in Part 1
Safety assessed by vital signs: Blood pressure in Part 2
Timeframe: Up to Day 24 in Part 2
Safety assessed by vital signs: Pulse rate in Part 1
Timeframe: Up to Day 12 in Part 1
Safety assessed by vital signs: Pulse rate in Part 2
Timeframe: Up to Day 24 in Part 2
Safety assessed by laboratory test: Hematology in Part 1
Timeframe: Up to Day 12 in Part 1
Safety assessed by laboratory test: Hematology in Part 2
Timeframe: Up to Day 24 in Part 2
Safety assessed by laboratory test: Biochemistry in Part 1
Timeframe: Up to Day 12 in Part 1
Safety assessed by laboratory test: Biochemistry in Part 2
Timeframe: Up to Day 24 in Part 2
Safety assessed by laboratory test: Urinalysis in Part 1
Timeframe: Up to Day 12 in Part 1
Safety assessed by laboratory test: Urinalysis in Part 2
Timeframe: Up to Day 24 in Part 2
Safety assessed by standard 12-lead electrocardiogram (ECG) in Part 1
Timeframe: Up to Day 12 in Part 1
Safety assessed by standard ECG in Part 2
Timeframe: Up to Day 24 in Part 2
Safety assessed by ECG parameters: Heart rate in Part 1
Timeframe: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: Heart rate in Part 2
Timeframe: Up to 24 hr after dosing on Day 10 in multiple dose (MD) of Part 2
Safety assessed by ECG parameters: QT interval in Part 1
Timeframe: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: QT interval in Part 2
Timeframe: Up to 24 hr after dosing on Day 10 in MD of Part 2
Safety assessed by ECG parameters: RR interval in Part 1
Timeframe: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: RR interval in Part 2
Timeframe: Up to 24 hr after dosing on Day 10 in MD of Part 2
Safety assessed by ECG parameters: PR interval in Part 1
Timeframe: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: PR interval in Part 2
Timeframe: Up to 24 hr after dosing on Day 10 in MD of Part 2
Safety assessed by ECG parameters: QRS interval in Part 1
Timeframe: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: QRS interval in Part 2
Timeframe: Up to 24 hr after dosing on Day 10 in MD of Part 2
Safety assessed by ECG parameters: QTc interval corrected by Fridericia method (QTcF) in Part 1
Timeframe: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: QTcF in Part 2
Timeframe: Up to 24 hr after dosing on Day 10 in MD of Part 2
Safety assessed by body weight in Part 1
Timeframe: Up to Day 3 in Part 1
Safety assessed by body weight in Part 2
Timeframe: Up to Day 15 in Part 2
Safety assessed by menstrual cycle in pre-menopausal females
Timeframe: Up to an average of two weeks after last dosing