Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose of 10 mg Immediate Release Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight

NCT ID: NCT04320771

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2018-12-17

Brief Summary

Neladenoson bialanate is currently under clinical development for a condition in which the heart has trouble pumping blood through the body (chronic heart failure). Renal impairment which co-occurs in patients with heart failure is a common condition in which the kidneys are not filtering the blood as well as they should. The goal of the study is to learn more about the safety of neladenoson bialanate, how it is tolerated and the way the body absorbs, distributes and excretes the study dug given as a single oral dose of 10 mg immediate release tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight

Detailed Description

Study was originally designed with 4 arms (normal renal function, mild, moderate, and severe renal impairment), however as the study was prematurely terminated, there was no participant with normal renal function enrolled

Conditions

Pharmacology, Clinical

Study Design

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

Study Groups

Neladenoson bialanate, mild renal impairment

Subjects with eGFR ≥60 - \<90 mL/min/1.73 received a single immediate-release (IR) tablet dose of 10 mg of neladenoson bialanate in the fasted state

Group Type: EXPERIMENTAL

Neladenoson bialanate (BAY 1067197)

Intervention Type: DRUG

10 mg as a single IR tablet dose. Active metabolite: BAY 84-3174

Neladenoson bialanate, moderate renal impairment

Subjects with eGFR ≥30 - \<60 mL/min/1.73 received a single IR tablet dose of 10 mg of neladenoson bialanate in the fasted state

Group Type: EXPERIMENTAL

Neladenoson bialanate (BAY 1067197)

Intervention Type: DRUG

10 mg as a single IR tablet dose. Active metabolite: BAY 84-3174

Neladenoson bialanate, severe renal impairment

Subjects with eGFR \<30 mL/min/1.73 received a single IR tablet dose of 10 mg of neladenoson bialanate in the fasted state

Group Type: EXPERIMENTAL

Neladenoson bialanate (BAY 1067197)

Intervention Type: DRUG

10 mg as a single IR tablet dose. Active metabolite: BAY 84-3174

Neladenoson bialanate, control group

Healthy subjects matched for age, gender and body weight received a single IR tablet dose of 10 mg neladenoson bialanate in the fasted state

Group Type: EXPERIMENTAL

Neladenoson bialanate (BAY 1067197)

Intervention Type: DRUG

10 mg as a single IR tablet dose. Active metabolite: BAY 84-3174

Interventions

Neladenoson bialanate (BAY 1067197)

10 mg as a single IR tablet dose. Active metabolite: BAY 84-3174

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

All subjects:

• Male or female White subjects (women without childbearing potential), aged 18 to 79 years (inclusive), body mass index 18 to 34 kg/m² (both inclusive)

Subjects with renal impairment:

• Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m² determined from serum creatinine 2-14 days prior to dosing using the Modification of Diet in Renal Disease equation
• Stable renal disease, i.e. 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.

Healthy subjects:

• Age-, weight- and gender matched healthy subjects

Exclusion Criteria

• An anatomical abnormality of the gut (e.g. gut surgery, continent ileostomy) that could affect the retention times of the drug in the stomach/gut adversely
• Gastric vagotomy or other condition that might adversely affect the gastric pH level
• Pancreatic dysfunction/insufficiency
• Febrile illness within 1 week prior to admission to study center
• Use of the following co-medications

From 2 weeks before administration until end of follow-up:

• Cytochrome P450 (CYP)3A4 inhibitors (Of note: grapefruit is a strong CYP3A4 inhibitor)
• CYP3A4 inducers
• CYP2C8 inhibitors (Of note: clopidogrel is a strong CYP2C8 inhibitor)
• Theophylline

On the day of dosing with neladenoson bialanate:

• Drugs that undergo significant systemic metabolism over gut wall uridine diphosphate-glucuronosyltransferase 1A1 (UGT1A1) substrates (e.g. irinotecan)
• Major breast cancer resistance protein (BCRP) substrates
• Regular daily consumption of more than 1 L - Plasmapheresis within 4 weeks before study drug administration
• Therapies (e.g. physiotherapy, acupuncture, etc.) within 1 week before study drug administration
• History of relevant and not cured cardiac rhythm disorders (i.e. Wolff-Parkinson-White syndrome, intermittent second- or third-degree AV block)
• Positive urine drug screening
• Subjects tested to be positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 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

Related Links

http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

2017-000795-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15138

Identifier Type: -

Identifier Source: org_study_id