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CompletedNCT02159313Updated Feb 18, 2016

Relative Bioavailability Study

A Phase 1 interventional study of Riociguat(Adempas,BAY63-2521) in Healthy Volunteers, sponsored by Bayer. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-18.

Sponsored by Bayer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Biological Availability
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • 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)

  • 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)

  • 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)

  • 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)

Interventions

  • DrugRiociguat(Adempas,BAY63-2521)

    Single dose of a whole 2.5 mg riociguat tablet

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: Up to 12 weeks

07

Study locations

1 site
  • Mönchengladbach, Nordrhein-Westfalen 41061, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02159313
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Jun 9, 2014
Start date
Jun 2014
Primary completion
Sep 2014
Completion
Jan 2015
Last update
Feb 18, 2016

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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