Eisai Trial Site #1
Bunkyō-Ku, Tokyo, Japan
NCT Number: NCT04683185
The primary purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple ascending oral doses of E6742 in Japanese healthy adult participants.
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Notify Me20 year–55 year
All sexes
Interventional
Phase 1
Bunkyō-Ku, Tokyo, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
E6742 tablets.
E6742-matched placebo tablets.
Time frame: Baseline up to 28 days after the last dose of study drug (approximately Day 35)
Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs; laboratory evaluation for hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and the performance of physical examinations.
Time frame: Day 1: 0-12 hours
Time frame: Day 1: 0-12 hours
Time frame: Day 1: 0-12 hours
Time frame: Day 1: 0-12 hours
Time frame: Day 7: 0-168 hours
Time frame: Day 7: 0-168 hours
Time frame: Day 7: 0-168 hours
Time frame: Day 7: 0-168 hours
Time frame: Day 7: 0-12 hours
Time frame: Day 7: 0-168 hours
Time frame: Day 7: 0-168 hours
Time frame: Day 7: 0-168 hours
Time frame: Day 7: 0-168 hours
Time frame: Day 7: 0-168 hours
Time frame: Day 7: 0-168 hours
Time frame: Day 7: 0-12 hours
Time frame: Day 1 and 7: 0-12 hours
High precision method QT analysis (HPQT) will be performed using data extracted from the 12-hour holter recording obtained from the morning of day 1 (predose) through 12 hours after dosing, the morning of day 7 (predose) through 12 hours after dosing.
Eisai Co., Ltd.
Industry
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Japanese Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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