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
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: 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 July 29, 2014