Relative Bioavailability Study

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Riociguat(Adempas,BAY63-2521)

• Registration Number: NCT02159313
• Lead Sponsor: Bayer

Brief Summary

To investigate relative bioavailability of crushed tablets suspended in apple sauce or water

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-09
• Primary Completion: 2014-09
• Study Completion: 2015-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-16
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BAY63-2521 with Non sparkling water	Riociguat(Adempas,BAY63-2521)	Single dose of a whole 2.5 mg riociguat tablet (fasted) with 240 mL of non-sparkling water at room temperature
BAY63-2521 after breakfast	Riociguat(Adempas,BAY63-2521)	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
BAY63-2521 with water	Riociguat(Adempas,BAY63-2521)	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)
BAY63-2521 with applesauce	Riociguat(Adempas,BAY63-2521)	Single dose of a crushed 2.5 mg riociguat tablet suspended in 50 mL applesauce, to be eaten with a spoon (fasted)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax)	Multiple time ponits up to day 3
Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC)	Multiple time points up to day 3

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability	Up to 12 weeks