This study should estimate the dose proportionality of BAY94-8862 IR tablets.
- Healthy male subject - Age: 18 to 46 years (inclusive) at the first screening examination - Ethnicity: White - Body mass index (BMI): >= 18 and <= 29.9 kg / m²
- Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec - Systolic blood pressure below 100 or above 140 mmHg - Diastolic blood pressure below 50 or above 90 mmHg - Heart rate below 50 or above 95 beats/ min - Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2) - Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)
CRS Clinical-Research-Services Mönchengladbach GmbH
Mönchengladbach, Germany, 41061
E-mail: [email protected]
Phone: (+)1-888-84 22937
Single center, randomized, open-label, 5-fold crossover study in healthy male subjects to investigate the pharmacokinetic dose proportionality of BAY94-8862 given as 5 different single oral IR tablet doses (1.25, 2.5, 5.0, 7.5 and 10 mg)