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 in Participants With Liver Impairment and Healthy Participants Matched for Age-, Gender-, and Weight

NCT ID: NCT04322253

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-24
• 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). Liver impairment is a condition in which the liver is not working 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 neladenoson bialanate in participants with liver impairment and healthy participants matched for age-, gender-, and weight

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 hepatic impairment

Subjects with Child Pugh score 5 or 6 received a single immediate-release (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

Neladenoson bialanate, moderate hepatic impairment

Subjects with Child Pugh score 7-9 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

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 and female Caucasian subjects between 18 and 79 years of age (both inclusive) with a body mass index above/equal 18.0 and below/equal 34.0 kg/m² Subjects with hepatic impairment
• Subjects with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan
• Subjects with hepatic impairment as per Child Pugh system
• Subjects with stable liver disease during the last 2 months Healthy subjects
• Healthy subjects with mean age and body weight not varying by more than ±10 years and ±10 kg from the groups of subjects with mild and moderate hepatic impairment, respectively.

Exclusion Criteria

• Medical history of continent ileostomy.
• Febrile illness within 1 week prior to admission to study center.
• Known hypersensitivity to the study drug (active substances or excipients of the preparation).
• Subjects with diagnosed malignancy within the past 5 years.
• Use of any systemic or topical medicine or substances which oppose the study objectives or which might influence them, in particular:

Starting from screening on, but minimum from 2 weeks before the study drug administration until the follow-up visit:

• CYP3A4 inducers
• CYP3A4 inhibitors
• Potent CYP2C8 inhibitors
• Major uridine diphosphate-glucuronosyltransferase isoenzyme 1A1 (UGT1A1) substrate (irinotecan)

On the day of administration of neladenoson bialanate:

• Major breast cancer resistance protein (BCRP) substrates
• Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of of more than 2 units of alcohol in another form - Intake of ethanol containing food and beverages from 48 h prior to admission to the study center until 96 h after study drug administration, afterwards not more than 2 units of alcohol per day until follow-up examination.
• Intake of food and beverages containing grapefruit or pomelo from 14 days prior to study drug administration up to the last time point of PK sampling.
• Therapies (e.g. physiotherapy, acupuncture, etc.) within 1 week before study drug administration.
• Positive urine drug screening.
• Positive results for human immune deficiency - Abnormal (clinically significant) thyroid stimulating hormone (TSH).

• 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

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

2017-000482-74

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15139

Identifier Type: -

Identifier Source: org_study_id