A Thorough Corrected QT Interval Trial

Completed · Phase 1 · Has a placebo group

Conditions studied: Dyslipidemia

In brief

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.

Key facts

Study ID

NCT02073084

Run by

Kowa Research Institute, Inc.

People needed

56

Starts

2014-01-01

Last updated by the study team

2015-04-10

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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