BAY94-8862, Rel. Bioavailability and food effect study
Primary objective: To investigate the pharmacokinetics (PK) of BAY 94-8862 after single oral doses of a 1.25 mg immediate release (IR) tablet, a 10 mg IR tablet and four 1.25 mg IR tablets (= 5 mg of BAY 94-8862) in the fasted state in healthy male subjects in a randomized, open-label, 3-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
- Clinically relevant changes/deviations from normal ECG, clinical examination, clinical chemistry, hematology, urinalysis, and/or blood pressure, heart rate (vital signs), or physical examination - Regular use of therapeutic or recreational drugs - Positive testing in drug screening and or alcohol breath test - Recent donation of blood/blood components - Subjects hypersensitive to the investigational drugs, their components and/or with a history of multiple drug allergies, non-allergic drug reactions, or severe allergies - History of / current relevant diseases of vital organs or of the central nervous system and/or medical conditions/disorder/illness that would impair subject’s ability to participate in the trial or that may affect study results, diagnosed malignancy, psychiatric disorders - Regular daily consumption of an amount of beer, alcohol, xanthine-containing beverages, and/or cigarettes that may affect study results - Intake of foods or beverages containing grapefruit within 2 weeks before study drug administration - Regular use of medicines and use of medication within the 2 weeks preceding the study, especially strong CYP3A4 inducers, weak to moderate CYP3A4 inhibitors and strong inhibitors of CYP3A4 or strong inhibitors of CYP2C8 - Excluded therapies (eg physiotherapy, acupuncture, etc) - Clinically relevant findings in the physical examination - Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2) (under Laboratory examinations) - Serum potassium level greater than equal to 5.0 mmol/L or serum sodium level less than equal to130 mmol/L
Wuppertal, Germany, 42096
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 1.25 mg IR tablet in comparison to a 10 mg IR tablet and 4 x 1.25 mg IR tablet in healthy male subjects in a randomized, open-label, three-fold crossover design.