Relative Bioavailability Study

NCT ID: NCT02159313

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-01-31

Brief Summary

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

BAY63-2521 with Non sparkling water

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

Group Type: EXPERIMENTAL

Riociguat(Adempas,BAY63-2521)

Intervention Type: DRUG

Single dose of a whole 2.5 mg riociguat tablet

BAY63-2521 with applesauce

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

Group Type: EXPERIMENTAL

Riociguat(Adempas,BAY63-2521)

Intervention Type: DRUG

Single dose of a whole 2.5 mg riociguat tablet

BAY63-2521 with water

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)

Group Type: EXPERIMENTAL

Riociguat(Adempas,BAY63-2521)

Intervention Type: DRUG

Single dose of a whole 2.5 mg riociguat tablet

BAY63-2521 after breakfast

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

Group Type: EXPERIMENTAL

Riociguat(Adempas,BAY63-2521)

Intervention Type: DRUG

Single dose of a whole 2.5 mg riociguat tablet

Interventions

Riociguat(Adempas,BAY63-2521)

Single dose of a whole 2.5 mg riociguat tablet

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Mönchengladbach, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

2013-005166-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17306

Identifier Type: -

Identifier Source: org_study_id