Effect of Riociguat on Bone Metabolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00855660
First received: March 3, 2009
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism.


Condition Intervention Phase
Effect of Riociguat on Bone Metabolism,
Drug: Riociguat (BAY63-2521)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Effect of Riociguat, Administered as 2.5 mg IR-tablets TID Over 14 Days, on Bone Metabolism in a Randomized, Placebo-controlled, Double-blind, 2-fold Cross-over Design in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The primary objective of this study is to investigate the effect of multiple-dose riociguat (2.5 mg tid over 14 days) on bone resorption and formation markers [ Time Frame: At each study day from day -1 to day 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigation of the pharmacokinetics of riociguat [ Time Frame: At each study day from day -1 to day 16 ] [ Designated as safety issue: No ]
  • Assessment of safety and tolerability [ Time Frame: At each study day from day -1 to day 16 ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: March 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: Riociguat (BAY63-2521)
The study drug riociguat will be given as a multiple administration in a dose of 2.5 mg administered tid over 14 days.
Placebo Comparator: Arm 2 Drug: Placebo
Placebo will be given as a multiple administration in a dose of 2.5 mg administered tid over 14 days.

  Eligibility

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

Inclusion Criteria:

  • Healthy male white subjects
  • 18 to 45 years of age
  • BMI between 18 and 28 kg/m2
  • Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period

Exclusion Criteria:

  • Relevant deviation from the normal range in the clinical examination; in clinical chemistry, hematology, or urinalysis
  • Resting heart rate in the awake subject below 45 BPM or above 90 BPM
  • Systolic blood pressure below 100 mmHg or above 145 mmHg
  • Diastolic blood pressure above 95 mmHg
  • Relevant pathological changes in the ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT / QTc-interval over 450 msec for males
  • History of genetic muscle or bone disease of any kind
  • Completely sedentary or extremely fit subjects
  • Fractures in the preceding 12 months
  • Psychiatric diseases
  • History of peptic ulcers or relevant gastro-esophageal reflux disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855660

Locations
Germany
Köln, Nordrhein-Westfalen, Germany, 51147
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00855660     History of Changes
Other Study ID Numbers: 13790, 2008-005569-70
Study First Received: March 3, 2009
Last Updated: February 18, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Bone Metabolism

ClinicalTrials.gov processed this record on April 17, 2014