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CompletedNCT04342273

A Through QT/QTc Study of KW-6356

A Through QT/QTc Study of KW-6356 in Japanese Healthy Adults

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
128 (actual)
Sponsor
Kyowa Kirin Co., Ltd. · Industry
Sex
All
Age
20 Years – 54 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGKW-6356KW-6356 will be administered once daily as therapeutic at Day 1 through Day 7
DRUGKW-6356KW-6356 will be administered once daily as supratherapeutic dose at Day 1 through Day 7
DRUGPlaceboPlacebo will be administered once daily at Day 1 through Day 7
DRUGMoxifloxacinPlacebo will be administered once daily at Day 1 through Day 6, followed by Moxifloxacin once daily at Day 7.

Timeline

Start date
2020-03-31
Primary completion
2020-09-05
Completion
2020-09-05
First posted
2020-04-13
Last updated
2020-09-18

Locations

2 sites across 1 country: Japan

Source: ClinicalTrials.gov record NCT04342273. Inclusion in this directory is not an endorsement.

A Through QT/QTc Study of KW-6356 (NCT04342273) · Clinical Trials Directory