Renal Impairment Study

Phase 1

Completed

• Conditions: Clinical Trial, Phase I
• Interventions: Drug: Fulacimstat (BAY1142524)

• Registration Number: NCT03402438
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-18
• Study Start: 2018-02-12
• Primary Completion: 2018-12-04
• Study Completion: 2019-03-19
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal (healthy subjects)	Fulacimstat (BAY1142524)	Healthy subjects matched for age, body weight and gender to the groups with renal impairment
Mildly renal impaired	Fulacimstat (BAY1142524)	Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m\*2
Moderately renal impaired	Fulacimstat (BAY1142524)	Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m\*2
Severely renal impaired	Fulacimstat (BAY1142524)	Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m\*2

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability	up to 10 days after dosing

Trial Locations

Locations (1)

CRS Clinical-Research-Services Kiel GmbH; 🇩🇪 Kiel, Schleswig-Holstein, Germany