Status:
TERMINATED
Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2082 in Healthy Male Subjects
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Healthy Participants
Eligibility:
MALE
20-85 years
Phase:
PHASE1
Brief Summary
This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending oral doses of E2082 in healthy Japanese adult and elderly male participants, and to eva...
Eligibility Criteria
Inclusion
- Participants must meet all of the following criteria to be included in this study:
- Non-smoking, age ≥20 years and \<55 years old adult male (Cohorts 1 to 9 of Part A and all cohorts of Part B), or age ≥55 years and ≤85 years old elderly male (only Cohort 10 of Part A) at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing.
- Body mass index ≥18 and \<30 kilograms per meters squared at Screening
Exclusion
- Participants who meet any of the following criteria will be excluded from this study:
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
- Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of E2082, example, hepatectomy, nephrectomy, and digestive organ resection
- Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, electrocardiogram finding, or laboratory test results that require medical treatment at Screening
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2020
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03402178
Start Date
December 21 2017
End Date
February 20 2020
Last Update
June 30 2021
Active Locations (1)
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1
Eisai Trial Site
Sumida-ku, Tokyo, Japan