Status:
COMPLETED
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Healthy Subjects
Eligibility:
All Genders
20-64 years
Phase:
PHASE1
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 ...
Detailed Description
This study consists of two parts. Part 1; Single Dose (SD) and Part 2; Single and Multiple Dose (SD and MD).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03436849
Start Date
February 22 2018
End Date
May 23 2018
Last Update
October 16 2024
Active Locations (1)
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1
Site JP00001
Fukuoka, Japan