Renal Impairment Study

Clinical Trial, Phase I Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402438
• Other study ID #: 18106
• Secondary ID: 2017-003301-17
• Status: Completed
• Phase: Phase 1
• Start date: February 12, 2018
• Est. completion date: March 19, 2019

Study information

• Verified date: March 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 19, 2019
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Trial, Phase I
• Renal Insufficiency

Intervention

Drug:
• Fulacimstat (BAY1142524)
single oral dose of 25 mg immediate-release tablet BAY1142524

Locations

Country	Name	City	State
Germany	CRS Clinical-Research-Services Kiel GmbH	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 8) >20% of AUC)	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
Primary	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
Primary	AUC of unbound drug (AUCu) of BAY1142524	AUC (0-tlast) u will be used if mean AUC (tlast 8) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.	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
Primary	Cmax of unbound drug (Cmax,u) of BAY1142524	An additional blood sample for fu will be collected at 2 hours after dosing.	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	Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability		up to 10 days after dosing

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