NCT04004195

Study to Investigate Safety, Absorption, Elimination, and Drug Effect of BAY2327949 in Participants With Different Renal Function Status

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Oral Dose of BAY2327949 Given as Immediate Release Tablet in Male and Female Participants in a Multi-center, Non-randomized, Non-controlled, Non-blinded Study With Group Stratification in Participants With Renal Impairment and Healthy Participants Matched for Age, Gender, and Weight

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. An additional important goal of this study is to gain more information on how well the study drug is tolerated and its effect on the human body functions. The study will enroll healthy participants or patients with mild, moderate or severe reduced kidney functions matched for age, weight and gender. The results of this study will help researchers to select the best dosing of the study drug for future studies in patients.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	BAY2327949	A single oral dose of 30 mg BAY2327949 given as one 30 mg IR tablet (dose might be reduced to 15 mg for group 4 according to safety assessment team decision)

Timeline

• Start date: 2019-07-10
• Primary completion: 2020-02-07
• Completion: 2020-06-04
• First posted: 2019-07-01
• Last updated: 2020-06-11

Locations

2 sites across 1 country: Germany