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
  • - Body mass index (BMI): 18 to 34 kg/m² (both inclusive)
    - Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).
    - Subjects with renal impairment:
    eGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.
    Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit
    - Healthy subjects
    eGFR ≥90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.
    Needs to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).


  • - Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)
    - Relevant impairment in liver function.
    - Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
    - Any organ transplant < 1 year before participation in this study.
    - Subject under dialysis or planned to start dialysis during participation in the study.
    - Failure of any other major organ system other than the kidney.

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