Trial Condition(s):
Effect of Riociguat on bone metabolism
13790
Not Available
Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism.
- 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
- 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
Locations | Status | |
---|---|---|
Locations Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR) Köln, Germany, 51147 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Crossover Assignment
Trial Arms:
2