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

Kowa

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: K-877; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02719431

K-877-108

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Warfarin/Warfarin + K-877

Other group

Treatment:

Drug: Warfarin

Drug: K-877