Relative Bioavailability and Food Effect Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01489488
First received: December 8, 2011
Last updated: April 4, 2014
Last verified: April 2014

December 8, 2011
April 4, 2014
December 2011
March 2012   (final data collection date for primary outcome measure)
Plasma concentration versus time profile of BAY63-2521 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01489488 on ClinicalTrials.gov Archive Site
Adverse event collection [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Adverse event collection [ Time Frame: 5 x 3 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Relative Bioavailability and Food Effect Study
Relative Bioavailability and Food Effect Study of Two Oral Liquid Formulations in Comparison to a 1mg Tablet of Riociguat to Characterize Its Pharmacokinetic Properties in Healthy Male and Female Adult Subjects in a Randomized, Open Label, 5 Fold Crossover Design

Relative bioavailability study in order to investigate different liquid formulations in comparison to a standard tablet

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Biological Availability
  • Drug: Riociguat (BAY63-2521)
    Single dose of 2.4 mg riociguat as paediatric high dose formulation (fasted)
  • Drug: Riociguat (BAY63-2521)
    Single dose of 2.4 mg riociguat as paediatric high dose formulation (fed)
  • Drug: Riociguat (BAY63-2521)
    Single dose of 0.3 mg riociguat as paediatric high dose formulation (fasted)
  • Drug: Riociguat (BAY63-2521)
    Single dose of 0.15 mg riociguat as paediatric low dose formulation (fasted)
  • Drug: Riociguat (BAY63-2521)
    Single dose of 1 mg riociguat tablet (fasted)
  • Experimental: Arm 1
    Intervention: Drug: Riociguat (BAY63-2521)
  • Experimental: Arm 2
    Intervention: Drug: Riociguat (BAY63-2521)
  • Experimental: Arm 3
    Intervention: Drug: Riociguat (BAY63-2521)
  • Experimental: Arm 4
    Intervention: Drug: Riociguat (BAY63-2521)
  • Experimental: Arm 5
    Intervention: Drug: Riociguat (BAY63-2521)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female volunteers
  • Age 18-45 years
  • Body mass index (BMI) 18.0-29.9 kg/m²
  • Systolic blood pressure (SBP) 110-145 mmHg
  • No drugs 2 weeks before treatment
  • Nonsmokers for at least 12 weeks

Exclusion Criteria:

  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
  • Medical disorder that would impair the subject's ability to complete the study in the opinion of the Investigator
  • Known hypersensitivity to the study drugs (active substance or excipients of the preparations)
  • Known severe allergies, non-allergic drug reactions, or multiple drug allergies
  • Relevant diseases within the last 4 weeks prior to the first study drug administration
  • Regular use of medicines
  • Regular use of therapeutic or recreational drugs
  • Use of any medication within the 2 weeks preceding the study
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01489488
14986, 2011-001893-24
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP