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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017684-42 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riociguat, Child Pugh A | Experimental | Participants with liver cirrhosis and mild hepatic impairment received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state |
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| Riociguat, Child Pugh B | Experimental | Participants with liver cirrhosis and moderate hepatic impairment received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state |
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| Riociguat, control A | Experimental | Healthy age-, weight-, and gender- matched participants to Child Pugh A group received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state |
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| Riociguat, control B | Experimental | Healthy age-, weight-, and gender- matched participants to Child Pugh B group received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat (Adempas, BAY 63-2521) | Drug | 0.5 mg riociguat as an immediate-release (IR) tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose for BAY 63-2521 and its metabolite M1 (BAY 60-4552) | Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| Cmax | Maximum total (bound and unbound) drug concentration in plasma after single dose administration for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| t½ | Half-life associated with the terminal slope for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| fu | Fraction unbound for BAY 63-2521 and its metabolite M1 | From 2 hours post-dose up to 24 hours post-dose |
| AUCu | AUC for unbound drug for BAY 63-2521 and its metabolite M1 | From 2 hours post-dose up to 24 hours post-dose |
| Cmax,u | Cmax for unbound drug for BAY 63-2521 and its metabolite M1 | From 2 hours post-dose up to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC/D | AUC divided by dose (mg) for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| AUCnorm | AUC divided by dose (mg) per kg body weight for BAY 63-2521 and its metabolite M1 |
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Inclusion criteria for all subjects:
Inclusion criteria for subjects with liver cirrhosis:
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:
Exclusion criteria for subjects with liver cirrhosis:
Exclusion criteria for healthy subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kiel | Schleswig-Holstein | 24105 | Germany |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| AUCu,norm | AUCnorm for unbound drug for BAY 63-2521 and its metabolite M1 | From 2 hours post-dose up to 24 hours post-dose |
| AUC(0-tlast) | AUC from time 0 to the last data point for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| Cmax/D | Cmax divided by dose (mg) for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| Cmax,norm | Cmax divided by dose (mg) per kg body weight for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| Cmax,u,norm | Cmax,norm for unbound drug for BAY 63-2521 and its metabolite M1 | From 2 hours post-dose up to 24 hours post-dose |
| tmax | Time to reach maximum drug concentration in plasma after single dose for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| MRT | Mean residence time for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| CL/F | Total body clearance of total (bound and unbound) drug from plasma calculated after oral administration (apparent oral clearance) for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| CLu/F | CL/F for unbound drug for BAY 63-2521 and its metabolite M1 | From 2 hours post-dose up to 24 hours post-dose |
| Vz/F | Apparent volume of distribution during terminal phase after oral administration for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only |
| AE,ur | Amount of (total) drug excreted in urine for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose |
| CLR | Renal body clearance of drug for BAY 63-2521 and its metabolite M1 | Pre-dose and up to 72 hours post-dose |
| Number of participants with adverse events | Approximately 5 weeks |
| ID | Term |
|---|---|
| C542595 | riociguat |
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