Study to Investigate Safety, Absorption, Elimination, and Drug Effect of BAY2327949 in Participants With Different Renal Function Status

Pharmacokinetics Clinical Trial

Official title:

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Oral Dose of BAY2327949 Given as Immediate Release Tablet in Male and Female Participants in a Multi-center, Non-randomized, Non-controlled, Non-blinded Study With Group Stratification in Participants With Renal Impairment and Healthy Participants Matched for Age, Gender, and Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04004195
• Other study ID #: 19224
• Secondary ID: 2019-000630-19
• Status: Completed
• Phase: Phase 1
• Start date: July 10, 2019
• Est. completion date: June 4, 2020

Study information

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

Clinical Trial Summary

BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. An additional important goal of this study is to gain more information on how well the study drug is tolerated and its effect on the human body functions. The study will enroll healthy participants or patients with mild, moderate or severe reduced kidney functions matched for age, weight and gender. The results of this study will help researchers to select the best dosing of the study drug for future studies in patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 4, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant must be =18 years of age

• The study enrolls healthy participants and participants at different stages of renal impairment (mild to severe renal impairment).

• Race: White

• BMI (body mass index): above or equal 18.5 and below or equal 35 kg/m*2 at the first screening visit.

• Male or female.

• Participants with renal impairment must have an eGFR (estimated glomerular filtration rate) <90 mL/min/1.73 m*2 determined from serum creatinine 21-3 days prior to dosing using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation (eGFR has to be repeated if screening period >10 days before dosing).

Stable renal function, e.g. a serum creatinine value determined at least 3 months before the pre-study visit should not vary by more than 25% from the serum creatinine value determined at the pre-study visit confirmed by nephrologist or general practitioner the patient is under care.

Exclusion Criteria:

• Clinically relevant findings in the physical examination affecting the objectives of the study.

• Systemic use of the following co-medications from 2 weeks before administration until end of follow-up:

• Moderate and strong inhibitors of CYP3A;

• Moderate and strong CYP3A inducers;

• Moderate and strong inhibitors of P-gp transport;

• UDP-glucuronosyltransferase (UGT) inhibitors probenecid and valproic acid.

• Regular daily consumption of more than 10 cigarettes.

• Acute renal failure.

• Active nephritis.

• Impairment of any other major organ system other than the kidney.

• Change in chronic medications for renal disease (or its consequences) less than 4 weeks prior to dosing.

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• BAY2327949
A single oral dose of 30 mg BAY2327949 given as one 30 mg IR tablet (dose might be reduced to 15 mg for group 4 according to safety assessment team decision)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of BAY2327949	Cmax: Maximum observed drug concentration in measured matrix after single dose administration	From pre-dose until follow-up (10-12 days after dosing).
Primary	AUC of BAY2327949	AUC:Area under the concentration vs. time curve from zero to infinity after single (first) dose.; AUC(0-tlast) will be used as primary variables if mean AUC(tlast-8) >20% of AUC	From pre-dose until follow-up (10-12 days after dosing).
Primary	Cmax,u of BAY2327949	Cmax,u: Cmax based on the unbound plasma concentrations of the study drug	From pre-dose until follow-up (10-12 days after dosing).
Primary	AUCu of BAY2327949	AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-8) >20% of AUC	From pre-dose until follow-up (10-12 days after dosing).
Secondary	Frequency and nature of treatment-emergent adverse events		Approximate 14 days (from starting treatment to end of follow-up)
Secondary	Urinary volume		From Day -1 until Day 4 (72h after dosing)
Secondary	Fluid balance		From Day -1 until Day 4 (72h after dosing)