check_circleStudy 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
  • - 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

  • - 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
48
Trial Dates
June 2014 - January 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Mönchengladbach, 41061, Germany

Primary Outcome

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

Secondary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 12 weeks
    enhanced_encryption
    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
4

Additional Information

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