NCT03235076

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	BAY1101042	Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)

Timeline

• Start date: 2017-08-15
• Primary completion: 2018-11-07
• Completion: 2019-03-13
• First posted: 2017-08-01
• Last updated: 2023-06-05

Locations

1 site across 1 country: Germany