Renal impairment study
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.
- 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.
CRS Clinical-Research-Services Kiel GmbH
Kiel, Germany, 24105
E-mail: [email protected]
Phone: (+) 1-888-8422937
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
Single Group Assignment