Status:
COMPLETED
Renal Impairment Study
Lead Sponsor:
Bayer
Conditions:
Clinical Trial, Phase I
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03402438
Start Date
February 12 2018
End Date
March 19 2019
Last Update
March 16 2020
Active Locations (1)
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1
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany, 24105