Investigation of Pharmacokinetics, Safety and Tolerability of a Single Oral Dose of BAY 3283142 in Participants With Renal Impairment Compared to an Age, Gender and Weight Matched Control Group in an Open-label Study Design

Bayer1 site in 1 country45 target enrollmentAugust 11, 2022

ConditionsChronic Kidney Disease Renal Impairment Healthy Volunteers

InterventionsSingle oral dose of BAY3283142 IR (immediate release) tablet

DrugsSingle oral dose of BAY3283142 IR (immediate release) tablet

Overview

Phase: Phase 1
Intervention: Single oral dose of BAY3283142 IR (immediate release) tablet
Conditions: Chronic Kidney Disease
Sponsor: Bayer
Enrollment: 45
Locations: 1
Primary Endpoint: AUC of BAY3283142
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD).

The kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. High blood pressure makes it more likely that the CKD gets worse.

The study treatment BAY3283142 is under development for treating CKD. It activates a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD.

The participants do not benefit from this study. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD.

In previous studies, BAY3283142 was studied in participants with normal kidney function. As kidneys play a role in removal of drugs from the body, the degree of kidney function could influence the amount of BAY3283142 in the blood. Higher amounts may occur in people with reduced kidney function.

Therefore, the main purpose of this study is to learn how the study treatment BAY3283142 moves into, through, and out of the body in participants with mild to severe reduction of kidney function compared to matched participants with normal kidney function.

To answer this, the researchers will compare:

the (average) total level of BAY3283142 in the blood (also called AUC).
the (average) highest level of BAY3283142 in the blood (also called cmax) between the different groups. Participants will be in one of four groups based on how much their kidney function is reduced (mild, moderate, severe, end stage kidney disease) or in the control group.

All participants will take a single dose of BAY3283142 as tablet by mouth. Each participant will be in the study for approximately 4 weeks including an in-house stay of 6 days (with 5 overnight stays). In addition, a screening visit to the study site before the in-house stay is planned.

During the study, the study team will:

check vital signs
do physical examinations
take blood and urine samples
examine heart health using an electrocardiogram (ECG)
ask the participants questions about how they are feeling and what adverse events they are having

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

Registry

clinicaltrials.gov

Start Date

August 11, 2022

End Date

June 6, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant must be 18 to 82 years of age inclusive, at the time of signing the informed consent.
•Normal kidney function or at different stages of renal impairment (mild to severe renal impairment, ESRD with hemodialysis or hemodiafiltration).
•Race: White (Note: Clinical Data Interchange Standards Consortium \[CDISC\] definition of White: Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White \[FDA\]).
•Body mass index (BMI) within the range 18.0 and 35.0 kg/m\^2 (both inclusive).
•Body weight equal or above 55 kg.
•Male or female participants; women have to be of non-childbearing potential as defined in Section 10.4.1 (e.g., postmenopausal for at least 1 year, women with bilateral salpingectomy, women with bilateral ovariectomy, and women with hysterectomy).
•Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
•Men must agree to use a condom in sexual intercourse with female partner of childbearing potential and not to act as sperm donor for 10 days after dosing.
•eGFR \<90 mL/min/1.73 m\^2 alculated by the CKD-EPI formula (eGFR must be repeated if screening period \>10 days before dosing) 21 to 2 days prior to dosing and patients with ESRD on hemodialysis or hemodiafiltration.
•Stable renal function (e.g., a serum creatinine value determined at least 3 months before the screening visit should not vary by more than 25% from the serum creatinine value determined at the screening visit).

Exclusion Criteria

•Women of childbearing potential, pregnant or lactating women.
•Medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator.
•Known or suspected liver disorders (including Morbus Gilbert/Meulengracht) and bile secretion/flow (cholestasis).
•Known hypersensitivity to the study drugs (active substances or excipients of the preparations).
•Known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids), urticaria, or significant non-allergic drug reactions.
•Relevant acute diseases within the last 4 weeks prior to intake of study intervention.
•Febrile illness within 2 weeks before intake of study intervention.
•Known tendency for vasovagal reactions (e.g., after venipuncture) or clinically relevant history of syncope.
•History of gastrointestinal surgery, with the exception of appendectomy unless it had been performed within the previous 12 months before screening.
•Acute diarrhea or constipation within 14 days before intake of study intervention.