Effect of Riociguat on Bone Metabolism - Full Text View

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

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

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:	Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00855660 History of Changes
Other Study ID Numbers:	13790, 2008-005569-70
Study First Received:	March 3, 2009
Last Updated:	March 1, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Bone Metabolism

ClinicalTrials.gov processed this record on September 26, 2012