check_circleStudy Completed
Clinical Trial, Phase I
Bayer Identifier:
18106
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Renal impairment study
Trial purpose
The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.
Key Participants Requirements
Sex
AllAge
18 - 79 YearsTrial summary
Enrollment Goal
36Trial Dates
February 2018 - March 2019Phase
Phase 1Could I Receive a placebo
NoProducts
Fulacimstat (BAY1142524)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical-Research-Services Kiel GmbH | Kiel, 24105, Germany |
Primary Outcome
- Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524AUC(0-tlast) will be used if mean AUC(tlast ∞) >20% of AUC)date_rangeTime Frame:Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
- Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524date_rangeTime Frame:Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
- AUC of unbound drug (AUCu) of BAY1142524AUC (0-tlast) u will be used if mean AUC (tlast ∞) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.date_rangeTime Frame:Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
- Cmax of unbound drug (Cmax,u) of BAY1142524An additional blood sample for fu will be collected at 2 hours after dosing.date_rangeTime Frame:Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
Secondary Outcome
- Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerabilitydate_rangeTime Frame:up to 10 days after dosing
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
N/AAssignment
Single Group AssignmentTrial Arms
4