Drug Interaction Study of Warfarin and MT-3995

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-09-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Healthy

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Warfarin and MT-3995

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.

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

MT-3995

Intervention Type DRUG

Interventions

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Warfarin

Intervention Type DRUG

MT-3995

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes