check_circleStudy Completed

Clinical Trial, Phase I

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

All

Age

18 - 79 Years

Trial summary

Enrollment Goal
36
Trial Dates
February 2018 - March 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
Fulacimstat (BAY1142524)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Kiel GmbHKiel, 24105, Germany

Primary Outcome

  • Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524
    AUC(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 BAY1142524
    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
  • AUC of unbound drug (AUCu) of BAY1142524
    AUC (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 BAY1142524
    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

Secondary Outcome

  • Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability
    date_rangeTime Frame:
    up to 10 days after dosing

Trial design

Investigation of pharmacokinetics, safety, and tolerability of a single oral 25 mg BAY 1142524 IR tablet dose in male and female subjects with renal impairment and in age-, gender-, and weight-matched healthy subjects in a single center, non-controlled, open-label, observational design
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
4