A Phase 1 Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects

Phase 1

• Conditions: Healthy Adult Subjects

• Registration Number: JPRN-jRCT2080223305
• Lead Sponsor: EA Pharma Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Male
• Target Recruitment: 68

Inclusion Criteria

(1) Japanese 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.
(2) Has voluntarily consented, in writing, to participate in this study.
(3) Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.

Exclusion Criteria

(1) History of surgical treatment that may affect the pharmacokinetics of the study drug at screening.
(2) 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, ECG findings, or laboratory values at screening or baseline.
(3) History of drug allergy at screening.
(4) Judged by the investigator or subinvestigator to be inappropriate for participation in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified