Renal Impairment Study

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT03402438

Collaborator

(none)

Enrollment

Location

Arms

13.1

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Trial, Phase I	Drug: Fulacimstat (BAY1142524)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Feb 12, 2018

Actual Primary Completion Date :

Dec 4, 2018

Actual Study Completion Date :

Mar 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal (healthy subjects) Healthy subjects matched for age, body weight and gender to the groups with renal impairment	Drug: Fulacimstat (BAY1142524) single oral dose of 25 mg immediate-release tablet BAY1142524
Experimental: Mildly renal impaired Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2	Drug: Fulacimstat (BAY1142524) single oral dose of 25 mg immediate-release tablet BAY1142524
Experimental: Moderately renal impaired Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2	Drug: Fulacimstat (BAY1142524) single oral dose of 25 mg immediate-release tablet BAY1142524
Experimental: Severely renal impaired Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2	Drug: Fulacimstat (BAY1142524) single oral dose of 25 mg immediate-release tablet BAY1142524

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRS Clinical-Research-Services Kiel GmbH	Kiel	Schleswig-Holstein	Germany	24105

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT03402438

Other Study ID Numbers:

18106
2017-003301-17

First Posted:

Jan 18, 2018

Last Update Posted:

Mar 16, 2020

Last Verified:

Mar 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Renal Insufficiency

Fulacimstat

Study Results

No Results Posted as of Mar 16, 2020