Drug Interaction Study of Warfarin and MT-3995

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MT-3995; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02531568

MT-3995-E10

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin

Full description

The purpose of this study is to evaluate the potential effects of multiple once daily doses of MT-3995 on the PK of (S)-warfarin and (R)-warfarin after single-dose administration of racemic warfarin

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able and willing to provide written informed consent to participate in this study
• Healthy, free from clinically significant illness or disease
• White Caucasian male or female, aged 18 to 55 years
• Body weight ranging from 50 (females) and 60 (males) to110 kg (inclusive)
• Must have coagulation test results (including international normalised ratio [INR] and activated partial thromboplastin time [aPTT]) within the laboratory reference range at Screening.

Exclusion criteria

• Presence or history of serious adverse reaction or allergy to any medicinal product
• Known contraindication or adverse reaction to warfarin.
• Presence of Cytochrome P450 2C9 (CYP2C9) and Vitamin K epoxide reductase complex subunit 1 (VKORC1) genetic polymorphisms that are known to increase warfarin sensitivity at Screening.
• Known contraindications to heparin administration.
• Known contraindication to parenteral vitamin K administration.

Trial design

20 participants in 1 patient group

Warfarin and MT-3995

Experimental group

Description:

Subjects will be administered a single dose of warfarin on day1. Subjects will be administered MT-3995 Days 8 to 20. Subjects will be administered MT-3995 and warfarin on Day21. Subjects will be administered MT-3995 from Day 22 to 27.

Treatment:

Drug: MT-3995

Drug: Warfarin