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

NCT04004195 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-06-11

No results posted yet for this study

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

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)

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-10
Primary Completion
2020-02-07
Completion
2020-06-04

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04004195 on ClinicalTrials.gov