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

NCT04004195 | Completed Phase 1

• 2 other identifiers: 192242019-000630-19
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• 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).

• 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-∞) \>20% of AUC

  From pre-dose until follow-up (10-12 days after dosing).

• 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).

• AUCu of BAY2327949

  AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC

  From pre-dose until follow-up (10-12 days after dosing).

Secondary Outcomes (3)

• Frequency and nature of treatment-emergent adverse events

  Approximate 14 days (from starting treatment to end of follow-up)

• Urinary volume

  From Day -1 until Day 4 (72h after dosing)

• Fluid balance

  From Day -1 until Day 4 (72h after dosing)

Study Arms (4)

Healthy participants

EXPERIMENTAL

Drug: BAY2327949

Participants with mild renal impairment

EXPERIMENTAL

Drug: BAY2327949

Participants with moderate renal impairment

EXPERIMENTAL

Drug: BAY2327949

Participants with severe renal impairment

EXPERIMENTAL

Drug: BAY2327949

Interventions

BAY2327949 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)

Healthy participants; Participants with mild renal impairment; Participants with moderate renal impairment; Participants with severe renal impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

APEX GmbH

München, Bavaria, 81241, Germany

Location

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, 24105, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 1, 2019
• Study Start: July 10, 2019
• Primary Completion: February 7, 2020
• Study Completion: June 4, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

DE (2)