A Thorough Corrected QT Interval Trial

April 9, 2015 updated by: Kowa Research Institute, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sequence A
Other: Placebo
Drug: Moxifloxacin
Drug: K-877 Low Dose
K-877 Low Dose
Drug: K-877 High Dose
K-877 High Dose
Other: Sequence B
Other: Placebo
Drug: Moxifloxacin
Drug: K-877 Low Dose
K-877 Low Dose
Drug: K-877 High Dose
K-877 High Dose
Other: Sequence C
Other: Placebo
Drug: Moxifloxacin
Drug: K-877 Low Dose
K-877 Low Dose
Drug: K-877 High Dose
K-877 High Dose
Other: Sequence D
Other: Placebo
Drug: Moxifloxacin
Drug: K-877 Low Dose
K-877 Low Dose
Drug: K-877 High Dose
K-877 High Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QTcI (QT interval corrected) duration
Time Frame: 24 hrs
24 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-877-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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