Drug Interaction Study of Warfarin and MT-3995
- Registration Number
- NCT02531568
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Warfarin and MT-3995 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. Warfarin and MT-3995 Warfarin 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.
- Primary Outcome Measures
Name Time Method Cmax of warfarin with MT-3995 versus warfarin alone 8 days AUC of warfarin with MT-3995 versus warfarin alone 8 days
- Secondary Outcome Measures
Name Time Method INR AUC of warfarin with MT-3995 versus warfarin alone 8 days International normalized ratio (INR) max of warfarin with MT-3995 versus warfarin alone 8 days
Trial Locations
- Locations (1)
Clinical research organization
🇩🇪Neu-Ulm, Wegenerstraße, Germany