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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02719431

Run by

Kowa Research Institute, Inc.

People needed

20

Starts

2016-01-01

Expected to finish

2016-02-01

Last updated by the study team

2016-03-25

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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