Status:
COMPLETED
Effect of Riociguat on Bone Metabolism
Lead Sponsor:
Bayer
Conditions:
Pharmacology, Clinical
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism.
Detailed Description
Clinical pharmacology
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00855660
Start Date
March 1 2009
End Date
July 1 2010
Last Update
January 11 2016
Active Locations (1)
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1
Cologne, North Rhine-Westphalia, Germany, 51147