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

NCT ID: NCT04004195

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-10
• Study Completion Date: 2020-06-04

Brief 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.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy participants

Group Type: EXPERIMENTAL

BAY2327949

Intervention Type: DRUG

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)

Participants with mild renal impairment

Group Type: EXPERIMENTAL

BAY2327949

Intervention Type: DRUG

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)

Participants with moderate renal impairment

Group Type: EXPERIMENTAL

BAY2327949

Intervention Type: DRUG

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)

Participants with severe renal impairment

Group Type: EXPERIMENTAL

BAY2327949

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

APEX GmbH

München, Bavaria, Germany

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

2019-000630-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

19224

Identifier Type: -

Identifier Source: org_study_id