Drug Interaction Study of Warfarin and MT-3995

October 7, 2015 updated by: Mitsubishi Tanabe Pharma Corporation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Wegenerstraße
      • Neu-Ulm, Wegenerstraße, Germany
        • Clinical Research Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Warfarin
Drug: MT-3995

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax of warfarin with MT-3995 versus warfarin alone
Time Frame: 8 days
8 days
AUC of warfarin with MT-3995 versus warfarin alone
Time Frame: 8 days
8 days

Secondary Outcome Measures

Outcome Measure
Time Frame
International normalized ratio (INR) max of warfarin with MT-3995 versus warfarin alone
Time Frame: 8 days
8 days
INR AUC of warfarin with MT-3995 versus warfarin alone
Time Frame: 8 days
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

  • Principal Investigator: Horst Heuer, Dr, Nuvisan GmBH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 20, 2015

First Posted (Estimate)

August 24, 2015

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-3995-E10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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