Clinical Trial, Phase I
Conditions
Brief summary
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.
Interventions
single oral dose of 25 mg immediate-release tablet BAY1142524
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524 | 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(0-tlast) will be used if mean AUC(tlast ∞) \>20% of AUC) |
| Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524 | 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 | 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 (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. |
| Cmax of unbound drug (Cmax,u) of BAY1142524 | 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 | An additional blood sample for fu will be collected at 2 hours after dosing. |
Secondary
| Measure | Time frame |
|---|---|
| Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability | up to 10 days after dosing |
Countries
Germany
Outcome results
None listed