Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets

Study Overview
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Brief Summary
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This study should estimate the dose proportionality of BAY94-8862 IR tablets.

Official Title
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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)

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: BAY94-8862 (1.25mg)
* Drug: BAY94-8862 (2.5mg)
* Drug: BAY94-8862 (5mg)
* Drug: BAY94-8862 (7.5mg)
* Drug: BAY94-8862 (10mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY94-8862 (1.25mg)<br>single dose BAY94-8862 IR tablet 1.25mg | Drug: BAY94-8862 (1.25mg)<br> <br> |
| Experimental: BAY94-8862 (2.5mg)<br>single dose BAY94-8862 IR tablet 2.5mg | Drug: BAY94-8862 (2.5mg)<br> <br> |
| Experimental: BAY94-8862 (5mg)<br>single dose BAY94-8862 IR tablet 5mg | Drug: BAY94-8862 (5mg)<br> <br> |
| Experimental: BAY94-8862 (7.5mg)<br>single dose BAY94-8862 IR tablet 7.5mg | Drug: BAY94-8862 (7.5mg)<br> <br> |
| Experimental: BAY94-8862 (10mg)<br>single dose BAY94-8862 IR tablet 10mg | Drug: BAY94-8862 (10mg)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets |  | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862 |  | Up to 48 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac disorders