Effect of Riociguat on Bone Metabolism

Bayer

Status and phase: Completed; Phase 1

Conditions: Pharmacology, Clinical

Treatments: Drug: Placebo; Drug: Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00855660

2008-005569-70 (EudraCT Number)

13790

Details and patient eligibility

About

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

Full description

Clinical pharmacology

Enrollment: 17 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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17 participants in 2 patient groups, including a placebo group

Riociguat

Active Comparator group

Description:

Subjects received multiple doses of riociguat (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days

Treatment:

Drug: Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg

Placebo

Placebo Comparator group

Description:

Subjects received placebo (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days

Treatment:

Drug: Placebo