Renal Impairment Study

Bayer

Status and phase: Completed; Phase 1

Conditions: Clinical Trial, Phase I

Treatments: Drug: Fulacimstat (BAY1142524)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03402438

2017-003301-17 (EudraCT Number)

18106

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

Normal (healthy subjects)

Experimental group

Description:

Healthy subjects matched for age, body weight and gender to the groups with renal impairment

Treatment:

Drug: Fulacimstat (BAY1142524)

Mildly renal impaired

Experimental group

Description:

Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m\*2

Treatment:

Drug: Fulacimstat (BAY1142524)

Moderately renal impaired

Experimental group

Description:

Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m\*2

Treatment:

Drug: Fulacimstat (BAY1142524)

Severely renal impaired

Experimental group

Description:

Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m\*2

Treatment:

Drug: Fulacimstat (BAY1142524)