Trial Condition(s):

Clinical Trial, Phase I

Renal impairment study

Bayer Identifier:

18106

ClinicalTrials.gov Identifier:

NCT03402438

EudraCT Number:

2017-003301-17

Study Completed

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.

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.

Trial Summary

Enrollment Goal
36
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Fulacimstat (BAY1142524)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical-Research-Services Kiel GmbH

Kiel, Germany, 24105

Status
Completed
 

Trial Design