Healthy
Conditions
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
Interventions
DRUGWarfarin
DRUGMT-3995
Sponsors
Tanabe Pharma Corporation
Study design
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of warfarin with MT-3995 versus warfarin alone | 8 days |
| AUC of warfarin with MT-3995 versus warfarin alone | 8 days |
Secondary
| Measure | Time frame |
|---|---|
| International normalized ratio (INR) max of warfarin with MT-3995 versus warfarin alone | 8 days |
| INR AUC of warfarin with MT-3995 versus warfarin alone | 8 days |
Countries
Germany
Outcome results
None listed