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
  Purpose

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


Condition Intervention Phase
Biological Availability
Drug: Riociguat (BAY63-2521)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Plasma concentration versus time profile of BAY63-2521 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event collection [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: December 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Riociguat (BAY63-2521)
Single dose of 2.4 mg riociguat as paediatric high dose formulation (fasted)
Experimental: Arm 2 Drug: Riociguat (BAY63-2521)
Single dose of 2.4 mg riociguat as paediatric high dose formulation (fed)
Experimental: Arm 3 Drug: Riociguat (BAY63-2521)
Single dose of 0.3 mg riociguat as paediatric high dose formulation (fasted)
Experimental: Arm 4 Drug: Riociguat (BAY63-2521)
Single dose of 0.15 mg riociguat as paediatric low dose formulation (fasted)
Experimental: Arm 5 Drug: Riociguat (BAY63-2521)
Single dose of 1 mg riociguat tablet (fasted)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489488

Locations
Germany
Köln, Nordrhein-Westfalen, Germany, 51063
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01489488     History of Changes
Other Study ID Numbers: 14986, 2011-001893-24
Study First Received: December 8, 2011
Last Updated: April 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Relative bioavailability study

ClinicalTrials.gov processed this record on April 16, 2014