Back to resultsA Thorough Corrected QT Interval Trial
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
K-877 Low Dose
Moxifloxacin
Placebo
K-877 High Dose
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Sequence A
Sequence B
Sequence C
Sequence D
Arm Description
Sequence A
Sequence B
Sequence C
Sequence D
Outcomes
Primary Outcome Measures
QTcI (QT interval corrected) duration
Secondary Outcome Measures
Full Information
NCT ID
NCT02073084
First Posted
February 25, 2014
Last Updated
April 9, 2015
Sponsor
Kowa Research Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02073084
Brief Title
A Thorough Corrected QT Interval Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Other
Arm Description
Sequence A
Arm Title
Sequence B
Arm Type
Other
Arm Description
Sequence B
Arm Title
Sequence C
Arm Type
Other
Arm Description
Sequence C
Arm Title
Sequence D
Arm Type
Other
Arm Description
Sequence D
Intervention Type
Drug
Intervention Name(s)
K-877 Low Dose
Intervention Description
K-877 Low Dose
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
K-877 High Dose
Intervention Description
K-877 High Dose
Primary Outcome Measure Information:
Title
QTcI (QT interval corrected) duration
Time Frame
24 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
City
Austin
State/Province
Texas
Country
United States
12. IPD Sharing Statement
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A Thorough Corrected QT Interval Trial
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