Multiple dose food effect Phase I study of BAY1021189
The primary objective of this study was to investigate the PK of BAY 1021189 after single oral doses of 1.25 mg, 2.5 mg, 5 mg and 10 mg administered as IR tablets in the fed state (high-fat, high-calorie breakfast).
The secondary objective of this study was to assess safety and tolerability of BAY 1021189.
- Healthy male subject - Age: 18 to 45 years (inclusive) at the first screening visit - Ethnicity: White - Body mass index (BMI): above/equal 18.0 and below/equal 29.9 kg/m²
- Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs was not normal - Known hypersensitivity to the study drug (active substances or excipients of the preparations) - Known severe allergies, non-allergic drug reactions, or multiple drug allergies - Relevant diseases within the last 4 weeks prior to study drug administration - Febrile illness within 1 week before study drug administration - History of postural syncopes - Regular use of medicines - Regular use of therapeutic or recreational drugs (eg carnitin products, anabolics, high dose vitamins) - Use of medication within 2 weeks before study drug administration which could oppose the study objectives or which might influence them
Köln, Germany, 51063
E-mail: [email protected]
Phone: Not Available
Relative bioavailability study to investigate pharmacokinetics, safety and tolerability following administration of 1.25 mg, 2.5 mg, 5 mg and 10 mg BAY 1021189 as IR tablets following a high fat, high calorie meal in 16 healthy male subjects in a randomized, open label, fourfold crossover design