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

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: ESN364

Study type: Interventional

Funder types: Industry

Identifiers

NCT03436849

2693-CL-0020

Details and patient eligibility

About

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.

Full description

This study consists of two parts. Part 1; Single Dose (SD) and Part 2; Single and Multiple Dose (SD and MD).

Enrollment: 44 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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44 participants in 9 patient groups, including a placebo group

ESN364 dose-1 group in Part 1

Experimental group

Description:

Healthy male subjects will receive a single dose of ESN364.

Treatment:

Drug: ESN364

ESN364 dose-2 group in Part 1

Experimental group

Description:

Healthy male subjects will receive a single dose of ESN364.

Treatment:

Drug: ESN364

Placebo group in Part 1

Placebo Comparator group

Description:

Healthy male subjects will receive a single dose of Placebo.

Treatment:

Drug: Placebo

Male ESN364 group in Part 2

Experimental group

Description:

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.

Treatment:

Drug: ESN364

Pre-menopausal female ESN364 group in Part 2

Experimental group

Description:

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.

Treatment:

Drug: ESN364

Post-menopausal female ESN364 group in Part 2

Experimental group

Description:

Healthy post-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.

Treatment:

Drug: ESN364

Male placebo group in Part 2

Placebo Comparator group

Description:

Healthy male subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days.

Treatment:

Drug: Placebo

Pre-menopausal female placebo group in Part 2

Placebo Comparator group

Description:

Healthy pre-menopausal female subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days.

Treatment:

Drug: Placebo

Post-menopausal female placebo group in Part 2

Placebo Comparator group

Description:

Healthy post-menopausal female subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days.

Treatment:

Drug: Placebo