Study Completed

Healthy volunteers

Bayer Identifier:

17306

ClinicalTrials.gov Identifier:

NCT02159313

EudraCT Number:

2013-005166-18

EU CT Number:

Not Available

Relative bioavailability study

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 45 Years

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 summary

Enrollment Goal

Trial Dates

June 2014 - January 2015

Phase

Phase 1

Could I Receive a placebo

Products

Adempas (Riociguat, BAY63-2521)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Mönchengladbach, 41061, Germany

Primary Outcome

Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC)
Time Frame:
Multiple time points up to day 3
Safety Issue:
No
Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax)
Time Frame:
Multiple time ponits up to day 3
Safety Issue:
No

Secondary Outcome

Number of participants with adverse events as a measure of safety and tolerability
Time Frame:
Up to 12 weeks
Safety Issue:
Yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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