Relative Bioavailability Study

Bayer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Riociguat(Adempas,BAY63-2521)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02159313

17306

2013-005166-18 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

48 participants in 4 patient groups

BAY63-2521 with Non sparkling water

Experimental group

Description:

Single dose of a whole 2.5 mg riociguat tablet (fasted) with 240 mL of non-sparkling water at room temperature

Treatment:

Drug: Riociguat(Adempas,BAY63-2521)

BAY63-2521 with applesauce

Experimental group

Description:

Single dose of a crushed 2.5 mg riociguat tablet suspended in 50 mL applesauce, to be eaten with a spoon (fasted)

Treatment:

Drug: Riociguat(Adempas,BAY63-2521)

BAY63-2521 with water

Experimental group

Description:

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)

Treatment:

Drug: Riociguat(Adempas,BAY63-2521)

BAY63-2521 after breakfast

Experimental group

Description:

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

Treatment:

Drug: Riociguat(Adempas,BAY63-2521)