NCT02073084

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

February 25, 2014

Last Update Submit

April 9, 2015

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • QTcI (QT interval corrected) duration

    24 hrs

Study Arms (4)

Sequence A

OTHER

Sequence A

Drug: K-877 Low DoseDrug: MoxifloxacinOther: PlaceboDrug: K-877 High Dose

Sequence B

OTHER

Sequence B

Drug: K-877 Low DoseDrug: MoxifloxacinOther: PlaceboDrug: K-877 High Dose

Sequence C

OTHER

Sequence C

Drug: K-877 Low DoseDrug: MoxifloxacinOther: PlaceboDrug: K-877 High Dose

Sequence D

OTHER

Sequence D

Drug: K-877 Low DoseDrug: MoxifloxacinOther: PlaceboDrug: K-877 High Dose

Interventions

K-877 Low DoseDRUG

K-877 Low Dose

Sequence ASequence BSequence CSequence D
MoxifloxacinDRUG
Sequence ASequence BSequence CSequence D
PlaceboOTHER
Sequence ASequence BSequence CSequence D
K-877 High DoseDRUG

K-877 High Dose

Sequence ASequence BSequence CSequence D

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Austin, Texas, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 27, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

US(1)