A Study to Assess the Safety, Tolerability, Pharmacokinet... | NCT03436849

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESN364 dose-1 group in Part 1	Experimental	Healthy male subjects will receive a single dose of ESN364.	Drug: ESN364
ESN364 dose-2 group in Part 1	Experimental	Healthy male subjects will receive a single dose of ESN364.	Drug: ESN364
Placebo group in Part 1	Placebo Comparator	Healthy male subjects will receive a single dose of Placebo.	Drug: Placebo
Male ESN364 group in Part 2	Experimental	Healthy male subjects will receive a single dose of ESN364 followed by washout period, then receive once daily dosing of ESN364 for 10 consecutive days at the same dose level.	Drug: ESN364
Pre-menopausal female ESN364 group in Part 2	Experimental	Healthy pre-menopausal female subjects will receive a single dose of ESN364 followed by washout period, then receive once daily dosing of ESN364 for 10 consecutive days at the same dose level.	Drug: ESN364
Post-menopausal female ESN364 group in Part 2

Name	Type	Description	Arm Group Labels	Other Names
ESN364	Drug	ESN364 will be administered orally.	ESN364 dose-1 group in Part 1 ESN364 dose-2 group in Part 1 Male ESN364 group in Part 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety assessed by incidence of adverse events (AEs) in Part 1	AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA).	Up to Day 12 in Part 1
Safety assessed by incidence of AEs in Part 2	AEs will be coded using MedDRA.	Up to Day 24 in Part 2
Safety assessed by vital signs: Body temperature in Part 1	To assess vital signs as a criterion of safety variables.	Up to day 12 in Part 1
Safety assessed by vital signs: Body temperature in Part 2	To assess vital signs as a criterion of safety variables.	Up to Day 24 in Part 2
Safety assessed by vital signs: Blood pressure in Part 1	To assess vital signs as a criterion of safety variables.	Up to Day 12 in Part 1
Safety assessed by vital signs: Blood pressure in Part 2	To assess vital signs as a criterion of safety variables.	Up to Day 24 in Part 2
Safety assessed by vital signs: Pulse rate in Part 1	To assess vital signs as a criterion of safety variables.	Up to Day 12 in Part 1
Safety assessed by vital signs: Pulse rate in Part 2

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK) parameter for ESN364 and its metabolite: Area under the concentration-time curve (AUC) from the time of dosing to time 24 h (AUC24) in plasma	To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.	Up to 48 hr after dosing in Part 1 and after first dosing in Part 2
PK parameter for ESN364 and its metabolite: AUC from the time of dosing extrapolated to time infinity (AUCinf) in plasma

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male subject between 20 to < 45 years of age, or female subject between 20 to < 65 years of age.
Body weight at screening: ≥ 50.0 kg and < 80.0 kg for male, ≥ 40.0 kg and < 70.0 kg for female.
Body mass index (BMI) at screening: range of ≥ 17.6 kg/m2 and < 26.4 kg/m2 [BMI = Body weight (kg) ÷ {Body height (m)2}].

Exclusion Criteria:

Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 84 days prior to screening.
Subject has had previous exposure with ESN364.
Subject has any clinically significant history of allergic conditions prior to study drug administration.
Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy.
Subject has contracted pyretic or symptomatic viral, bacterial, or fungal infection within 7 days prior to hospital admission.
Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission.
Subjects who has any significantly abnormal results of laboratory tests at screening or on the day of hospital admission.
Subjects who are positive for any of urinary drug abuse test or serology test at screening.
Subject took a drug or underwent therapy within 2 weeks prior to hospital admission.
Subjects used a drug or underwent therapy that affects sex hormones within 3 months prior to hospital admission.
Subjects who had bilateral orchiectomy.
Subject has used any inducer of metabolism in the 3 months prior to hospital admission.
Subject has a history of smoking more than 10 cigarettes per day within 3 months prior to screening test.
Subject consumes, on average, more than approximately 500 mg/day of caffeine
Subject has a history of consuming more than 30 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to screening.
Subjects who conducted or is scheduled to conduct any blood donation or blood drawing.

Name	Affiliation	Role
Medical Director	Astellas Pharma Inc	Study Director

IPD Sharing Statement Module