Jan. 20, 2021 |
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Dec. 05, 2021 |
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jRCT2031200316 |
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Japanese Healthy Adult Subjects |
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A Study to Assess the Safety and Tolerability of E6742 in Japanese Healthy Adult Participants |
Kitahara Yasumi |
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Eisai Co., Ltd. |
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4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan |
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+81-3-3817-5245 |
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eisai-chiken_hotline@hhc.eisai.co.jp |
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Japan and Asia Clinical Development Department Neurology Business Group |
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Eisai Co., Ltd. |
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4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan |
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+81-3-3817-5245 |
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eisai-chiken_hotline@hhc.eisai.co.jp |
Complete |
Dec. 28, 2020 |
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Dec. 28, 2020 | ||
24 | ||
Interventional |
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randomized controlled trial |
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double blind |
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placebo control |
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parallel assignment |
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other |
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1. Non-smoking, male or female Japanese, greater than or equal to (>=) age 20 years and less than or equal to (<=) 55 years old at the time of informed consent |
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1. Females who are breastfeeding or pregnant at Screening or Baseline |
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20age old over | ||
55age old under | ||
Both |
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Systemic Lupus Erythematosus |
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Intervention:Drug administration and blood collection |
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Plasma concentration of compound(s)/ Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
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Change From Baseline in Corrected QT Interval (QTc) for E6742 |
Eisai Co., Ltd. |
Japan Agency for Medical Research and Development (AMED) | |
Applicable |
The Institutional Review Board, the University of Tokyo Hospital | |
7-3-1, Hongo, Bunkyo-ku, Tokyo | |
+81-3-5800-8743 |
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IRBjimu-tokyo@umin.ac.jp | |
Approval | |
Yes |
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https://www.eisai.com/company/business/research/clinical/index.html |
NCT04683185 | |
ClinicalTrials.gov |
none |