Drug Interaction Study of Warfarin and MT-3995

A Phase I, Open-label, Single-Centre, Drug-Drug Interaction Study to Evaluate the Influence of MT-3995 on Pharmacokinetics(PK) and Pharmacodynamics of Warfarin in Healthy Subjects

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

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

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.