The study aims to investigate the effect of YM150 and to compare gender and ethnic differences in healthy Caucasian and Japanese male and female subjects.
Each dose group consists of a cohort of 8 Caucasian and 8 Japanese male subjects to be randomized such that 6 subjects of each race receive active treatment and 2 subjects of each race receive matching placebo. The highest tolerated dose is repeated with a cohort of 8 Caucasian and 8 Japanese female subjects, unless emerging safety and PK information justifies higher dose levels or require additional female dose groups. Each subject is administered a single dose YM150 or placebo on Day 1 followed by multiple doses of YM150 or placebo once daily on Days 3 to 9.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
82
FOCUS Clinical Drug Development GmbH
Neuss, Germany
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events
Time frame: Day -21 - Day 25
Pharmacokinetics (PK) and pharmacodynamics (PD) of YM150 assessed by plasma and urine concentrations
Cmax (Maximum concentration), tmax (Time to attain Cmax), t1/2 (Apparent terminal elimination half-life), Vz/F (Apparent volume of distribution), CL/F (Apparent total body plasma clearance), CLR (Renal clearance), PTmax (Maximum Prothrombin time), aPTTmax (Maximum activated partial thromboplastin time), AUClast (AUC until last sample taken), AUC0-inf (AUC extrapolated until infinity), AUC0-24h (AUC between time 0 and 24h), Aelast (Amount excreted in urine until last sample), Ae0-inf (Amount excreted in urine extrapolated until infinity), %Excrlast, %Excr0-inf, %Excr0-24h and Ae0-24h (Amount excreted in urine between time 0 and 24h)
Time frame: Day 1 - Day 11
Gender effects on the PK and PD of YM150.
Cmax, tmax, t1/2, Vz/F, CL/F, CLR, PTmax, aPTTmax, AUClast, AUC0-inf, AUC0-24h, Aelast, Ae0-inf, %Excrlast, %Excr0-inf, %Excr0-24h and Ae0-24h
Time frame: Day 1 - Day 11
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.