NCT02719431

Brief Summary

The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the pharmacokinetics of warfarin in healthy adults volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_1 healthy

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, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2016

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

1 month

First QC Date

January 29, 2016

Last Update Submit

March 21, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • International normalized ratio (INR)

    22 Days

Study Arms (1)

Warfarin/Warfarin + K-877

OTHER
Drug: WarfarinDrug: K-877

Interventions

WarfarinDRUG
Warfarin/Warfarin + K-877
K-877DRUG
Warfarin/Warfarin + K-877

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 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 clinically significant out-of-range PT, INR, activated partial thromboplastin time, fibrinogen, protein C, or protein S.
  • Subject has abnormal prolongation of skin bleeding time at Screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Austin, Texas, United States

Location

MeSH Terms

Interventions

WarfarinK-877 compound

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2016

First Posted

March 25, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 25, 2016

Record last verified: 2016-03

Locations

US(1)