check_circleStudy Completed
Pharmacokinetics
Bayer Identifier:
19224
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to investigate safety, absorption, elimination, and drug effect of BAY2327949 in participants with different renal function status
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
32Trial Dates
July 2019 - June 2020Phase
Phase 1Could I Receive a placebo
NoProducts
BAY2327949Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical-Research-Services Kiel GmbH | Kiel, 24105, Germany |
Completed | APEX GmbH | München, 81241, Germany |
Primary Outcome
- Cmax of BAY2327949Cmax: Maximum observed drug concentration in measured matrix after single dose administrationdate_rangeTime Frame:From pre-dose until follow-up (10-12 days after dosing).
- AUC of BAY2327949AUC:Area under the concentration vs. time curve from zero to infinity after single (first) dose. AUC(0-tlast) will be used as primary variables if mean AUC(tlast-∞) >20% of AUCdate_rangeTime Frame:From pre-dose until follow-up (10-12 days after dosing).
- Cmax,u of BAY2327949Cmax,u: Cmax based on the unbound plasma concentrations of the study drugdate_rangeTime Frame:From pre-dose until follow-up (10-12 days after dosing).
- AUCu of BAY2327949AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) >20% of AUCdate_rangeTime Frame:From pre-dose until follow-up (10-12 days after dosing).
Secondary Outcome
- Frequency and nature of treatment-emergent adverse eventsdate_rangeTime Frame:Approximate 14 days (from starting treatment to end of follow-up)
- Urinary volumedate_rangeTime Frame:From Day -1 until Day 4 (72h after dosing)
- Fluid balancedate_rangeTime Frame:From Day -1 until Day 4 (72h after dosing)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
4