Relative Bioavailability Study

Study Overview
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Brief Summary
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To investigate relative bioavailability of crushed tablets suspended in apple sauce or water

Official Title
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Relative Bioavailability Study of Riociguat Given Orally as a Crushed 2.5 mg Tablet Suspended in Applesauce, Crushed 2.5 mg Tablet Suspended in Water, and Whole 2.5 mg Tablet After a Continental Breakfast in Comparison to a Whole 2.5 mg Tablet Given in the Fasted State to Characterize the Pharmacokinetic Properties in Healthy Male Adult Subjects in a 4-fold Crossover Design

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Riociguat(Adempas,BAY63-2521)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subject Age: 18 to 45 years (inclusive) at the first screening examination Ethnicity: white Body mass index (BMI): >18 and <29.9 kg/m2 Exclusion Criteria: Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, or effects of the study drug will not be normal History of coronary artery disease Symptomatic postural hypotension (e.g. dizziness, lightheadedness) History of bronchial asthma or any other airway disease Smoking (former smokers who have stopped smoking at least 3 months before the first study drug administration may be included) Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 ms or of the QTc interval (QT interval corrected for heart rate) over 450 ms Systolic blood pressure below 100 or above 145 mmHg Diastolic blood pressure below 50 or above 95 mmHg Heart rate below 45 or above 95 beats per minute

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY63-2521 with Non sparkling water<br>Single dose of a whole 2.5 mg riociguat tablet (fasted) with 240 mL of non-sparkling water at room temperature | Drug: Riociguat(Adempas,BAY63-2521)<br>* Single dose of a whole 2.5 mg riociguat tablet<br>|
| Experimental: BAY63-2521 with applesauce<br>Single dose of a crushed 2.5 mg riociguat tablet suspended in 50 mL applesauce, to be eaten with a spoon (fasted) | Drug: Riociguat(Adempas,BAY63-2521)<br>* Single dose of a whole 2.5 mg riociguat tablet<br>|
| Experimental: BAY63-2521 with water<br>Single dose of a crushed 2.5 mg riociguat tablet suspended in a glass with 25 mL water, to be drunk and flushed twice with 25 mL water in the same glass (fasted) | Drug: Riociguat(Adempas,BAY63-2521)<br>* Single dose of a whole 2.5 mg riociguat tablet<br>|
| Experimental: BAY63-2521 after breakfast<br>Single dose of a whole 2.5 mg riociguat tablet taken within 5 minutes after the last bite of a continental breakfast (fed) with 240 mL of non-sparkling water at room temperature | Drug: Riociguat(Adempas,BAY63-2521)<br>* Single dose of a whole 2.5 mg riociguat tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC) |  | Multiple time points up to day 3 | 
| Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax) |  | Multiple time ponits up to day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability |  | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biological Availability