Trial Condition(s):

Pharmacology, clinical

Effect of Riociguat on bone metabolism

Bayer Identifier:

13790

ClinicalTrials.gov Identifier:

NCT00855660

EudraCT Number:

2008-005569-70

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
17
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR)

Köln, Germany, 51147

Status
Completed
 

Trial Design