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Renal Impairment Study

Primary Purpose

Clinical Trial, Phase I

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Fulacimstat (BAY1142524)

About this trial

This is an interventional other trial for Clinical Trial, Phase I

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

CRS Clinical-Research-Services Kiel GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Normal (healthy subjects)

Mildly renal impaired

Moderately renal impaired

Severely renal impaired

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524

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

AUC of unbound drug (AUCu) of BAY1142524

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

An additional blood sample for fu will be collected at 2 hours after dosing.

Secondary Outcome Measures

Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability

Full Information

NCT ID

NCT03402438

First Posted

January 11, 2018

Last Updated

March 13, 2020

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT03402438

Brief Title

Renal Impairment Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

February 12, 2018 (Actual)

Primary Completion Date

December 4, 2018 (Actual)

Study Completion Date

March 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clinical Trial, Phase I

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal (healthy subjects)

Arm Type

Experimental

Arm Description

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

Arm Title

Mildly renal impaired

Arm Type

Experimental

Arm 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

Arm Title

Moderately renal impaired

Arm Type

Experimental

Arm 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

Arm Title

Severely renal impaired

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Fulacimstat (BAY1142524)

Intervention Description

single oral dose of 25 mg immediate-release tablet BAY1142524

Primary Outcome Measure Information:

Title

Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524

Description

AUC(0-tlast) will be used if mean AUC(tlast ∞) >20% of AUC)

Time Frame

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

Title

Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524

Time Frame

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

Title

AUC of unbound drug (AUCu) of BAY1142524

Description

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.

Time Frame

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

Title

Cmax of unbound drug (Cmax,u) of BAY1142524

Description

An additional blood sample for fu will be collected at 2 hours after dosing.

Time Frame

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

Secondary Outcome Measure Information:

Title

Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability

Time Frame

up to 10 days after dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

Facility Name

CRS Clinical-Research-Services Kiel GmbH

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

12. IPD Sharing Statement

Links:

URL

https://clinicaltrials.bayer.com/

Description

Click here to find results for studies related to Bayer products.

URL

http://www.clinicaltrialsregister.eu/

Description

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

Renal Impairment Study

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