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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 22, 2014