Effect of Riociguat on Bone Metabolism

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Riociguat

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

• Subjects with hypersensitivity to the investigational drug riociguat or ranitidine, or to inactive constituents

• Regular daily consumption of more than half a liter of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form, more than 1 L of xanthine-containing beverages, recent smoking history

• Use of medication within the 2 weeks preceding the study which could have interfered with the investigational drug riociguat or ranitidine

• Subjects with a medical disorder, condition or history of such that would have impaired the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor