Trial Condition(s):

Clinical Pharmacology

Study on the safety of BAY 63-2521, how it is tolerated and the way the body absorbs, distributes and gets rid of the study drug given as a single oral dose of 1 mg tablet in participants with impaired liver function and healthy participants matched for age-, gender-, and weight

Bayer Identifier:

15001

ClinicalTrials.gov Identifier:

NCT04366622

EudraCT Number:

2009-017684-42

Study Completed

Trial Purpose

BAY 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. Renal impairment is a common condition in patients with this disease. The goal of the study is to learn more about the safety of BAY 63-2521, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 1 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight

Inclusion Criteria
- Male and female White subjects 18 to ≤79 years of age, BMI between 18 and 34 kg/m^2
- Women without childbearing potential or with childbearing potential but only if the pregnancy test is negative and are under highly effective contraception 
 
Inclusion criteria for subjects with liver cirrhosis:
- Documented liver cirrhosis confirmed by histopathology, eg previous liver biopsy, laparoscopy, or ultrasound Hepatic impairment (Child Pugh A or B)
- Stable liver disease

Inclusion criteria for healthy subjects:
- Age- (+/-10 years), weight- (+/-10 kg body weight), and gender-matched to a subject with liver cirrhosis as far as possible

Exclusion criteria for all subjects:
- Febrile illness within 1 week before the start of the study
- Hypersensitivity to riociguat and / or to inactive constituents
- Smoking

Exclusion criteria for subjects with liver cirrhosis:
- Hemoglobin <8 g/dL
- Severe cerebrovascular or cardiac disorders, eg myocardial infarction less than 6 months prior to dosing, congestive heart failure of NYHA grade III or IV, severe arrhythmia requiring antiarrhythmic treatment
- Evidence of hepatic encephalopathy related to chronic liver disease > Grade II
- Renal failure with a creatinine clearance <40 mL/min
- Resting heart rate in the awake subject below 45 BPM or above 100 BPM
- Systolic blood pressure (SBP) below 100 mmHg or above 160 mmHg, Diastolic blood pressure (DBP) above 95 mmHg
- Platelet count <30 x 10^9/L
- History of bleeding within the past 3 months
- AP >4 times the upper limit of normal (ULN)
- AST or ALT in conjunction with GGT >= 4 times the ULN (an isolated elevation of GGT >4 times ULN did not exclude the subject)
- Serum albumin <20 g/L
- Diabetes mellitus with a fasting blood glucose >220 mg/dL or HbA1c >10%
- Prothrombin time (Quick test) <30%
- Subjects who had undergone porto-caval shunt surgery
- Use of medications known to interfere with hepatic metabolism (eg cimetidine, barbiturates, phenothiazines, etc) or known to alter other major organs or systems within 30 days prior to dosing
- Severe infection, malignancy, psychosis, or any clinically significant illness within 4 weeks prior to dosing
- Concomitant use of any medication except medications necessary for the treatment of the kidney disease or related complications
- Concomitant use of phosphodiesterase-5 inhibitors, endothelin receptor antagonists (ERAs, eg bosentan), intravenous or inhalative prostacyclins, or nitrates 
- Concomitant use of potent CYP3A4 and P-gp inhibitors

Exclusion criteria for healthy subjects:
- Conspicuous findings in medical history or pre-study examination
- History of relevant diseases of vital organs, central nervous system, or other organs
- Resting heart rate in the awake subject below 45 BPM or above 90 BPM
- SBP below 100 mmHg or above 145 mmHg, DBP above 95 mmHg
- Regular daily consumption of more than 1 liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
32
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kiel, Germany, 24105

Status
Completed
 

Trial Design