Trial Condition(s):
Multiple dose food effect Phase I study of BAY1021189
16440
Not Available
Not Available
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
Locations | Status | |
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Locations Investigative Site Köln, Germany, 51063 | Status Completed | Contact Us: 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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
4
Not Available