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

NCT ID: NCT03436849

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2018-05-23

Brief 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.

Detailed Description

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

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

ESN364 dose-1 group in Part 1

Healthy male subjects will receive a single dose of ESN364.

Group Type: EXPERIMENTAL

ESN364

Intervention Type: DRUG

ESN364 will be administered orally.

ESN364 dose-2 group in Part 1

Healthy male subjects will receive a single dose of ESN364.

Group Type: EXPERIMENTAL

ESN364

Intervention Type: DRUG

ESN364 will be administered orally.

Placebo group in Part 1

Healthy male subjects will receive a single dose of Placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally.

Male ESN364 group in Part 2

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.

Group Type: EXPERIMENTAL

ESN364

Intervention Type: DRUG

ESN364 will be administered orally.

Pre-menopausal female ESN364 group in Part 2

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.

Group Type: EXPERIMENTAL

ESN364

Intervention Type: DRUG

ESN364 will be administered orally.

Post-menopausal female ESN364 group in Part 2

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.

Group Type: EXPERIMENTAL

ESN364

Intervention Type: DRUG

ESN364 will be administered orally.

Male placebo group in Part 2

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally.

Pre-menopausal female placebo group in Part 2

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally.

Post-menopausal female placebo group in Part 2

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally.

Interventions

ESN364

ESN364 will be administered orally.

Intervention Type: DRUG

Placebo

Placebo will be administered orally.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Site JP00001

Fukuoka, , Japan

Countries

Japan

Other Identifiers

2693-CL-0020

Identifier Type: -

Identifier Source: org_study_id