A Thorough Corrected QT Interval Trial
| Status: | Recruiting |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 3/16/2015 |
| Start Date: | January 2014 |
| Contact: | Roger Morgan, MD, FACS |
| Email: | Info@kowaus.com |
| Phone: | 919-433-1600 |
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.
focus on cardiac repolarization compared with placebo in healthy adult subjects.
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.
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