Status:
WITHDRAWN
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Adult Male Participants
Lead Sponsor:
EA Pharma Co., Ltd.
Conditions:
Healthy Participants
Eligibility:
MALE
20-44 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of E6130 in Japanese healthy adult male participants.
Eligibility Criteria
Inclusion
- Participants must meet all of the following criteria to be included in this study.
- Japanese or Caucasian healthy adult males aged ≥20 and \<45 years at the time of informed consent who are non-smokers or able to stop smoking from at least 4 weeks before study drug administration until the post-treatment examination
- Has voluntarily consented, in writing, to participate in this study
- Has been thoroughly briefed on the conditions for participation in the study, and are willing and able to comply with the conditions
Exclusion
- Participants who meet any of the following criteria will be excluded from this study.
- History of surgical treatment may affect the pharmacokinetics of the study drug at screening
- Suspected to have clinically abnormal symptoms or impairment of organ function requiring treatment on the basis of history and complications at screening, and physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline
- History of drug allergy at screening
- Judged by the investigator or sub investigator to be inappropriate for participation in this study
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03390647
Start Date
December 21 2017
End Date
March 1 2019
Last Update
July 31 2018
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