Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects

Single/Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY1101042 Given as 5 mg MR Tablet After Single Oral Dosing Followed by Once Daily Dosing for 7 Days in 12 Healthy Male Subjects Per Dose Step in a Randomized, Placebo Controlled, Single Blind, Group Comparison Design

To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days

Inclusion Criteria:

• The informed consent must be signed before any study specific tests or procedures are done.
• Healthy male subject.
• Age: 18 to 45 years (inclusive) at the screening.
• Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.
• Ability to understand and follow study-related instructions.

Exclusion Criteria:

• Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
• Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening.
• Regular use of medicines.
• Smoking more than 10 cigarettes daily.
• Systolic blood pressure below 100 or above 145 mmHg (at screening).
• Diastolic blood pressure below 50 or above 90 mmHg (at screening).
• Heart rate below 50 or above 90 beats/ min (at screening).