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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: BAY1101042

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • CRS Clinical-Research-Services Kiel GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): November 7, 2018
• Study Completion (Actual): March 13, 2019

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: 18745; 2017-001141-28 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No