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Trial record 1 of 1 for:    NCT02159313
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Relative Bioavailability Study

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ClinicalTrials.gov Identifier: NCT02159313
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
To investigate relative bioavailability of crushed tablets suspended in apple sauce or water

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Riociguat(Adempas,BAY63-2521) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: Riociguat(Adempas,BAY63-2521)
Single dose of a whole 2.5 mg riociguat tablet
Experimental: 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)
 Drug: Riociguat(Adempas,BAY63-2521)
Single dose of a whole 2.5 mg riociguat tablet
Experimental: 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)
 Drug: Riociguat(Adempas,BAY63-2521)
Single dose of a whole 2.5 mg riociguat tablet
Experimental: 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
 Drug: Riociguat(Adempas,BAY63-2521)
Single dose of a whole 2.5 mg riociguat tablet


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC) [ Time Frame: Multiple time points up to day 3 ]
  2. Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax) [ Time Frame: Multiple time ponits up to day 3 ]

Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159313


Locations
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Germany
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02159313    
Other Study ID Numbers: 17306
2013-005166-18 ( EudraCT Number )
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016
Keywords provided by Bayer:
Biological Availability
Additional relevant MeSH terms:
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Riociguat
Enzyme Activators
Molecular Mechanisms of Pharmacological Action