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
- Registration Number
- NCT04364464
- 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
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Riociguat, healthy participants Riociguat (Adempas, BAY 63-2521) Participants with creatinine clearance (CLCR) \>80 mL/min received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state Riociguat, moderate renal impairment Riociguat (Adempas, BAY 63-2521) Participants with CLCR 30-\<50 mL/min received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state Riociguat, severe renal impairment Riociguat (Adempas, BAY 63-2521) Participants with CLCR \<30 mL/min received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state Riociguat, mild renal impairment Riociguat (Adempas, BAY 63-2521) Participants with CLCR 50-80 mL/min 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 up to 72 hours post-dose 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,u From 2 hours post-dose up to 24 hours post-dose Cmax for unbound drug for BAY 63-2521 and its metabolite M1
Cmax Pre-dose up to 72 hours post-dose Maximum total (bound and unbound) drug concentration in plasma after single dose administration for BAY 63-2521 and its metabolite M1
t½ Pre-dose up to 72 hours post-dose Half-life associated with the terminal slope 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
fu From 2 hours post-dose up to 24 hours post-dose Fraction unbound for BAY 63-2521 and its metabolite M1
- Secondary Outcome Measures
Name Time Method Cmax/D Pre-dose up to 72 hours post-dose Cmax divided by dose 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
CLR From 24 hours prior to drug administration up to 72 hours post-dose Renal body clearance of drug for BAY 63-2521 and its metabolite M1
AE,ur From 24 hours prior to drug administration up to 72 hours post-dose Amount of (total) drug excreted in urine for BAY 63-2521 and its metabolite M1
AUCnorm Pre-dose up to 72 hours post-dose AUC divided by dose 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
tmax Pre-dose up to 72 hours post-dose Time to reach Cmax (in case of two identical Cmax values, the first tmax was used) for BAY 63-2521 and its metabolite M1
MRT Pre-dose up to 72 hours post-dose Mean residence time for BAY 63-2521 and its metabolite M1
CL/F Pre-dose up to 72 hours post-dose Total body clearance of drug calculated after extravascular administration (eg 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
Number of participants with adverse events Approximately 5 weeks AUC(0-tlast) Pre-dose up to 72 hours post-dose AUC from time 0 to the last data point for BAY 63-2521 and its metabolite M1
AUC/D Pre-dose up to 72 hours post-dose AUC divided by dose for BAY 63-2521 and its metabolite M1
Cmax,norm Pre-dose up to 72 hours post-dose Cmax divided by dose per kg body weight for BAY 63-2521 and its metabolite M1
Vz/F Pre-dose up to 72 hours post-dose Apparent volume of distribution during terminal phase after extravascular administration for BAY 63-2521 and its metabolite M1