BAY94-8862,Relative bioavailability and food effect study
Primary objective: To investigate pharmacokinetics of BAY 94-8862 after single oral doses of 10 mg polyethylene glycol solution, 10 mg immediate release (IR) tablet and eight 10 mg IR tablets (= 80 mg of BAY 94-8862) in the fasted state and 10 mg IR tablet with a high-fat, high-calorie breakfast in healthy male subjects in a randomized, open-label, four-fold crossover design.
Secondary objectives: To assess safety and tolerability of BAY 94-8862.
- Healthy male white subjects; 18 to 46 years of age; body mass index: ≥18 and ≤29.9 kg/m*2.
- Subjects with conspicuous findings in medical history and pre-study examination - Recent donation of blood/blood components - Clinically relevant changes/deviations from normal electrocardiography, physical examination, clinical chemistry, hematology, urinalysis, and/or blood pressure, heart rate (vital signs) - Regular daily consumption of an amount of beer, alcohol, xanthine-containing beverages, foods or beverages containing grapefruit and/or cigarettes that may affect study results - History of/current relevant diseases of vital or other organs and of the central nervous system and/or medical conditions that would impair subject’s ability to participate in the trial or that may affect study results - Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies or with hypersensitivity to the investigational drug, the control agent and/or to inactive constituents - Regular use of therapeutic or recreational drugs - Use of medication within the 2 weeks preceding the study, especially, Concomitant administration of potassium-sparing diuretics, ACE inhibitors, angiotensin-II-receptor blockers, potassium or calcium supplements, nonsteroidal anti-inflammatory drugs like acetylsalicylic acid, indomethacin or ibuprofen, concomitant use of strong CYP3A4 inducers and inhibitors, weak to moderate CYP3A4 inhibitors - Subjects testing positive in the drug screening or alcohol breath test - Subject testing positive for human immunodeficiency virus type 1 and 2 antibody, hepatitis B surface antigen or hepatitis C virus antibody - Serum potassium level greater than equal to 5.0 mmol/L, serum sodium level less than equal to 130 mmol/L
Köln, Germany, 51063
E-mail: [email protected]
Phone: (+)1-888-84 22937
Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of single oral doses of BAY 94-8862 given as 10 mg IR tablet in comparison to a 10 mg solution and 8 x 10 mg IR tablet in the fasting condition and to investigate the effect of a high fat, high calorie meal on the 10 mg IR tablet in healthy male subjects in a randomized, open-label, four-fold crossover design