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A Through QT/QTc Study of KW-6356

NCT04342273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2020-09-18

No results posted yet for this study

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

DRUG

KW-6356

KW-6356 will be administered once daily as therapeutic at Day 1 through Day 7

DRUG

KW-6356

KW-6356 will be administered once daily as supratherapeutic dose at Day 1 through Day 7

DRUG

Placebo

Placebo will be administered once daily at Day 1 through Day 7

DRUG

Moxifloxacin

Placebo will be administered once daily at Day 1 through Day 6, followed by Moxifloxacin once daily at Day 7.

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2020-09-05
Completion
2020-09-05

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04342273 on ClinicalTrials.gov