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
- Registration Number
- NCT04366622
- Lead Sponsor
- Bayer
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Riociguat, Child Pugh B Riociguat (Adempas, BAY 63-2521) 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 Riociguat, Child Pugh A Riociguat (Adempas, BAY 63-2521) 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 Riociguat, control A Riociguat (Adempas, BAY 63-2521) 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 Riociguat, control B Riociguat (Adempas, BAY 63-2521) 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
- Primary Outcome Measures
Name Time Method AUC Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only 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)
Cmax Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only Maximum total (bound and unbound) drug concentration in plasma after single dose administration for BAY 63-2521 and its metabolite M1
t½ Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only Half-life associated with the terminal slope for BAY 63-2521 and its metabolite M1
fu From 2 hours post-dose up to 24 hours post-dose Fraction unbound for BAY 63-2521 and its metabolite M1
Cmax,u From 2 hours post-dose up to 24 hours post-dose Cmax for unbound drug for BAY 63-2521 and its metabolite M1
AUCu From 2 hours post-dose up to 24 hours post-dose AUC for unbound drug for BAY 63-2521 and its metabolite M1
- Secondary Outcome Measures
Name Time Method AUC/D Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only AUC divided by dose (mg) for BAY 63-2521 and its metabolite M1
tmax Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only Time to reach maximum drug concentration in plasma after single dose for BAY 63-2521 and its metabolite M1
CLR Pre-dose and up to 72 hours post-dose Renal body clearance of drug for BAY 63-2521 and its metabolite M1
Number of participants with adverse events Approximately 5 weeks Vz/F Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only Apparent volume of distribution during terminal phase after oral administration for BAY 63-2521 and its metabolite M1
Cmax,norm Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only Cmax divided by dose (mg) per kg body weight for BAY 63-2521 and its metabolite M1
AUCnorm Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only AUC divided by dose (mg) per kg body weight for BAY 63-2521 and its metabolite M1
AUCu,norm From 2 hours post-dose up to 24 hours post-dose AUCnorm for unbound drug for BAY 63-2521 and its metabolite M1
Cmax,u,norm From 2 hours post-dose up to 24 hours post-dose Cmax,norm for unbound drug for BAY 63-2521 and its metabolite M1
CL/F Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only 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
CLu/F From 2 hours post-dose up to 24 hours post-dose CL/F for unbound drug for BAY 63-2521 and its metabolite M1
AUC(0-tlast) Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only AUC from time 0 to the last data point for BAY 63-2521 and its metabolite M1
Cmax/D Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only Cmax divided by dose (mg) for BAY 63-2521 and its metabolite M1
MRT Pre-dose and up to 72 hours post-dose, additionally up to 96 hours post-dose for Child Pugh B group only Mean residence time for BAY 63-2521 and its metabolite M1
AE,ur Pre-dose and up to 72 hours post-dose Amount of (total) drug excreted in urine for BAY 63-2521 and its metabolite M1