Dyslipidemia
Conditions
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.
Interventions
DRUGK-877 Low Dose
K-877 Low Dose
DRUGMoxifloxacin
OTHERPlacebo
DRUGK-877 High Dose
K-877 High Dose
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QTcI (QT interval corrected) duration | 24 hrs |
Countries
United States
Outcome results
None listed