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Drug Interaction Study of Warfarin and MT-3995

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ClinicalTrials.gov Identifier: NCT02531568
Recruitment Status : Completed
First Posted : August 24, 2015
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Warfarin Drug: MT-3995 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Cmax of warfarin with MT-3995 versus warfarin alone [ Time Frame: 8 days ]
  2. AUC of warfarin with MT-3995 versus warfarin alone [ Time Frame: 8 days ]

Secondary Outcome Measures :
  1. International normalized ratio (INR) max of warfarin with MT-3995 versus warfarin alone [ Time Frame: 8 days ]
  2. INR AUC of warfarin with MT-3995 versus warfarin alone [ Time Frame: 8 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531568


Locations
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Germany
Clinical research organization
Neu-Ulm, Wegenerstraße, Germany
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Principal Investigator: Horst Heuer, Dr Nuvisan GmbH

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02531568     History of Changes
Other Study ID Numbers: MT-3995-E10
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Warfarin
Anticoagulants