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Trial record 21 of 740 for:    warfarin

Drug Interaction Study of Warfarin and MT-3995

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 4, 2015
First Posted Date  ICMJE August 24, 2015
Last Update Posted Date October 9, 2015
Study Start Date  ICMJE June 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
  • Cmax of warfarin with MT-3995 versus warfarin alone [ Time Frame: 8 days ]
  • AUC of warfarin with MT-3995 versus warfarin alone [ Time Frame: 8 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02531568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
  • International normalized ratio (INR) max of warfarin with MT-3995 versus warfarin alone [ Time Frame: 8 days ]
  • INR AUC of warfarin with MT-3995 versus warfarin alone [ Time Frame: 8 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Interaction Study of Warfarin and MT-3995
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Warfarin
  • Drug: MT-3995
Study Arms  ICMJE 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.
Interventions:
  • Drug: Warfarin
  • Drug: MT-3995
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02531568
Other Study ID Numbers  ICMJE MT-3995-E10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitsubishi Tanabe Pharma Corporation
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Horst Heuer, Dr Nuvisan GmbH
PRS Account Mitsubishi Tanabe Pharma Corporation
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP