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 renal impairment and healthy participants matched for age-, gender-, and weight

Bayer Identifier:

15000

ClinicalTrials.gov Identifier:

NCT04364464

EudraCT Number:

2009-017685-23

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 with 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 renal failure:
- Stable renal disease, ie. a serum creatinine value determined at least 3 - 6 months before the pre-study visit was not allowed to vary by more than 20% from the serum creatinine value determined at the pre-study visit

Inclusion criteria for healthy subjects:
- Mean age and body weight not allowed to vary by more than +/- 10 years and +/- 10 kg from the subjects with renal impairment, respectively

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 renal failure:
- Resting heart rate in the awake subject below 45 BPM or above 90 BPM
- Acute renal failure or nephritis
- Any organ transplant
- Diastolic blood pressure (DBP) >100 mmHg and / or systolic blood pressure (SBP) >180 mmHg 
- Hemoglobin <8 g/dL, Proteinuria >8 g/24 hours, Serum albumin <30 g/L, Platelet count <100 x 109/L
- History of bleeding within the past 3 months
- Diabetes mellitus with a fasting blood glucose >220 mg/dL or HbA1c >10%
- 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 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
- SBP below 100 mmHg or above 145 mmHg and / or 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
40
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