Single dose escalation Phase I study in Asians
The primary objective of this study was to investigate the safety and tolerability of BAY 1021189 after single oral doses of 1.25 mg, 5 mg and 10 mg administered as one or multiples of 1.25 mg immediate-release(IR) tablet(s) in Asian (Chinese) healthy male subjects.
The secondary objectives of this study are to investigate
pharmacokinetics and pharmacodynamics of BAY1021189 in Asian (Chinese) healthy male subjects.
- Healthy male subject - Age: 21 to 45 years (inclusive) at the first screening examination / visit - Chinese healthy male subject - Body weight ≥50 kg, Body Mass Index (BMI) was between 19 and 27 kg/m² (inclusive)
- Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not normal - Known hypersensitivity to the study drugs (active substances or excipients of the preparations) or to the study drugs, the control agent and / or to inactive constituents - Known severe allergies, non-allergic drug reactions, or multiple drug allergies - Relevant diseases within the last 4 weeks prior to the first study drug administration - Febrile illness within 1 week before the first study drug administration - Regular use of medicines - Regular use of therapeutic or recreational drugs - Use of systemic or topical medicines or substances which could oppose the study objectives or which could influence them within 4 weeks before the first study drug administration - Smoking more than 20 cigarettes daily - Regular daily consumption of more than 800 mL of usual beer or the equivalent quantity of approximately 32 g of alcohol in another form
Singapore, Singapore, 529889
E-mail: [email protected]
Phone: Not Available
Single-center, randomized, double-blind, placebo-controlled, single dose escalation study to investigate safety, tolerability and pharmacokinetics of BAY 1021189 in Asian (Chinese) healthy male subjects