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Drug-Drug Interaction Study to Assess the Effects of Multiple-Dose Administration of K-877 on the Pharmacodynamics and the Pharmacokinetics of Multiple-Dose Administration of Warfarin in Healthy Adult Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02719431
Enrollment
20
Registered
2016-03-25
Start date
2016-01-31
Completion date
2016-02-29
Last updated
2016-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGWarfarin
DRUGK-877

Sponsors

Kowa Research Institute, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
International normalized ratio (INR)22 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026