Status:
COMPLETED
A Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese Subjects
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Healthy Subjects
Eligibility:
MALE
20-85 years
Phase:
PHASE1
Brief Summary
This study will be a single-center, single dose, randomized, double-blind, placebo-controlled study in healthy Japanese male subjects. The study will consist of 2 parts: Part A (young subjects) and Pa...
Eligibility Criteria
Inclusion
- Parts A and B
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
- Part A: Young cohort
- Non-smoking, male subjects age \>=20 years and less than 55 years old at the time of informed consent
- Part B: Elderly Cohort
- Non-smoking, male subjects age \>=65 years and less than 85 years old at the time of informed consent
Exclusion
- Subjects who meet any of the following criteria will be excluded from this study:
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Any history of abdominal surgery that may affect PK profiles of E2307 (eg. hepatectomy, nephrectomy, digestive organ resection)
- Known history of clinically significant drug allergy (at Screening)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02289599
Start Date
November 1 2014
End Date
July 1 2015
Last Update
January 18 2016
Active Locations (1)
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1
Kagoshima, Kagoshima-ken, Japan