This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and tolerability of warfarin alone and combined with YM178.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Unnamed facility
Paris, France
R- and S-warfarin in plasma: AUCinf, AUClast, Cmax, tmax, t1/2, CL/F
Time frame: Day 1-9 and 15-31
The AUCinf of both enantiomers will be used to assess the potential drug-drug interaction.
Time frame: Day 1/2 and 15/16
Adverse events, clinical laboratory tests (hematology, biochemistry, urinalysis), vital signs, 12-lead ECG, physical examination
Time frame: Day -1 - 31
YM178 in plasma: Ctrough, AUCtau, Cmax, tmax, CL/F
Time frame: Day 20-24
Degree of anticoagulation: AUCPT;0-168h (area under the prothrombin time versus time curve from 0 to 168 h after dosing with warfarin), AUCINR;0-168h, maximum PT (PTmax), time to reach PTmax (tPT; max), INRmax, tINR;max
Time frame: Day 1-9 and 23-31
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