A Thorough Corrected QT Interval Trial

Dyslipidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073084
• Other study ID #: K-877-102
• Status: Completed
• Phase: Phase 1
• First received: February 25, 2014
• Last updated: April 9, 2015
• Start date: January 2014

Study information

• Verified date: April 2015
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• K-877 Low Dose
K-877 Low Dose
• Moxifloxacin

Other:
• Placebo

Drug:
• K-877 High Dose
K-877 High Dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTcI (QT interval corrected) duration		24 hrs	No