A Thorough Corrected QT Interval Trial

Phase 1

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: K-877 Low Dose; Drug: Moxifloxacin; Other: Placebo; Drug: K-877 High Dose

• Registration Number: NCT02073084
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

The purpose of this study is to determine the effects of K-877 on ECG parameters with a focus on cardiac repolarization compared with placebo in healthy adult subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Primary Completion: 2014-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Subject provides written informed consent before any study specific evaluation is performed.
• Subject is a healthy adult male or female volunteer, of any race and ethnicity, between the ages of 18 and 45 years, inclusive.
• Subject has a body mass index of 18 to 30 kg/m2, inclusive.

Exclusion Criteria

• Subject has clinically relevant abnormalities in the screening or check in assessments.
• Subject has a supine blood pressure after resting for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic.
• Subject has a supine Heart Rate (HR) (as measured at Screening or Check-in during collection of vital signs) after resting for at least 5 minutes that is outside the range of 40 to 90 beats per minute.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B	K-877 Low Dose	Sequence B
Sequence A	K-877 High Dose	Sequence A
Sequence C	K-877 Low Dose	Sequence C
Sequence B	Moxifloxacin	Sequence B
Sequence C	K-877 High Dose	Sequence C
Sequence D	K-877 High Dose	Sequence D
Sequence A	K-877 Low Dose	Sequence A
Sequence A	Placebo	Sequence A
Sequence B	Placebo	Sequence B
Sequence B	K-877 High Dose	Sequence B
Sequence C	Placebo	Sequence C
Sequence D	K-877 Low Dose	Sequence D
Sequence D	Placebo	Sequence D
Sequence A	Moxifloxacin	Sequence A
Sequence C	Moxifloxacin	Sequence C
Sequence D	Moxifloxacin	Sequence D

Primary Outcome Measures

Name	Time	Method
QTcI (QT interval corrected) duration	24 hrs