A Thorough Corrected QT Interval Trial

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kowa Research Institute, Inc.
• Treatments: Moxifloxacin

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.