Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 Tablet Dose in Men and Woman With Renal Impairment and in Healthy Subjects

Study Overview
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Brief Summary
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To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.

Official Title
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Investigation of Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 MR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight- Matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: BAY1101042


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and follow study-related instructions and ability to participate in the study for the entire period. Age: 18 to 79 years (inclusive) at the screening visit. Body mass index (BMI): 18 to 34 kg/m² (both inclusive). Male or female subject. Only women without childbearing potential will be included in the study (e.g. postmenopausal for at least one year, women with bilateral ovariectomy and women with hysterectomy). Subjects with renal impairment: eGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2-10 days prior to dosing. Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit. Healthy subjects: - eGFR ≥90 mL/min/1.73 m*2 determined from serum creatinine 2-10 days prior to dosing. Exclusion Criteria: Pregnant or lactating women. Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with mild renal impairment<br>Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) | Drug: BAY1101042<br>* Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)<br>|
| Experimental: Subjects with moderate renal impairment<br>Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) | Drug: BAY1101042<br>* Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)<br>|
| Experimental: Subjects with severe renal impairment<br>Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) | Drug: BAY1101042<br>* Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)<br>|
| Experimental: Matched healthy subject group<br>Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) | Drug: BAY1101042<br>* Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042 | Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042 | Study Day 1 to Study Day 6 | 
| Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042 | Maximum observed concentration of BAY1101042 in plasma after single dose administration | Study Day 1 to Study Day 6 | 
| AUCu of BAY1101042 | Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042 | Study Day 1 to Study Day 6 | 
| Cmax,u of BAY1101042 | Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042 | Study Day 1 to Study Day 6 |