Clinical trial NCT04004195: Study to Investigate Safety, Absorption, Elimination, and Drug Effect of BAY2327949 in Participants With Different Renal Function Status
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Cmax of BAY2327949
timeFrame: From pre-dose until follow-up (10-12 days after dosing).
measure: AUC of BAY2327949
timeFrame: From pre-dose until follow-up (10-12 days after dosing).
measure: Cmax,u of BAY2327949
timeFrame: From pre-dose until follow-up (10-12 days after dosing).
measure: AUCu of BAY2327949
timeFrame: From pre-dose until follow-up (10-12 days after dosing).
Secondary outcomes:
measure: Frequency and nature of treatment-emergent adverse events
timeFrame: Approximate 14 days (from starting treatment to end of follow-up)
measure: Urinary volume
timeFrame: From Day -1 until Day 4 (72h after dosing)
measure: Fluid balance
timeFrame: From Day -1 until Day 4 (72h after dosing)
Other outcomes:
Locations:
city: München
country: Germany
facility: APEX GmbH
state: Bayern
city: Kiel
country: Germany
facility: CRS Clinical-Research-Services Kiel GmbH
state: Schleswig-Holstein
Study officials:
References: