Age and Gender Effects on the Pharmacokinetics of BAY85-3934
Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days. The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the 5 days of the study.
- No diagnosis of any specific disease or condition - Subjects are expected to be in good general health for their respective age range - Male or female gender - Age subgroups: 1) 18 to 45 years (inclusive) and 2) 65 to 85 years (inclusive) - Racial group: Caucasian
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal. This includes moderate and severe renal impairment (on dialysis or not), and moderate or severe hepatic disease. - Clinically relevant findings in the physical examination
Fargo, United States, 58104
E-mail: [email protected]
Phone: Not Available
A Parallel Group, Double-Blind Study to Evaluate the Effects of Age and Gender on the Single-Dose Pharmacokinetics of BAY85-3934, Tablet Formulation