drugset / Trial / 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

NCT03235076 ↗

Phase 1 Completed 36 enrolled Bayer
Non-randomizedSingle-groupOpen-labelOther

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.

Timeline

Start
2017-08-15
Primary completion
2018-11-07
Completion
2019-03-13

Drugs

EvaluationDrugModalityDoseRoute
Subject BAY1101042 Unknown 10 mg Oral