KW-6356
DrugKW-6356 will be administered once daily as therapeutic at Day 1 through Day 7
NCT Number: NCT04342273
The purpose of this study is to evaluate the effects of multiple therapeutic and supratherapeutic doses of KW-6356 on the QT interval corrected for heart rate in Japanese healthy adults.
Looking for future studies?
Notify Me20 year–54 year
All sexes
Interventional
Phase 1
Medical Co. LTA Sumida Hospital, Sumida-ku, Tokyo, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hypokalemia, hypocalcemia, and/or long QT syndrome Risk factors for torsade de pointes such as cardiac failure, cardiomyopathy, and a family history of long QT syndrome Sick sinus syndrome, second- or third-degree atrioventricular block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, QT interval prolongation, or atrioventricular conduction disturbance Repeated or frequent syncope or vasovagal attack Hypertension, angina pectoris, bradycardia, or severe peripheral arterial circulatory disorder
KW-6356 will be administered once daily as therapeutic at Day 1 through Day 7
Placebo will be administered once daily at Day 1 through Day 7
Placebo will be administered once daily at Day 1 through Day 6, followed by Moxifloxacin once daily at Day 7.
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 20
Time frame: Day 1 through Day 8, and Day 12
Kyowa Kirin Co., Ltd.
Industry
A Through QT/QTc Study of KW-6356 in Japanese Healthy Adults
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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