Investigation of the Pharmacokinetics, Safety, and Tolerability of Neladenoson Bialanate in Subjects With Hepatic Impairment (Classified as Child Pugh A and B) and in Age-, Weight-, and Gender-matched Healthy Subjects, Following a Single Oral Dose in a Single-center, Non-randomized, Non-controlled, Non-blinded Study

Bayer1 site in 1 country22 target enrollmentAugust 24, 2017

ConditionsPharmacology, Clinical

InterventionsNeladenoson bialanate (BAY 1067197)

DrugsNeladenoson bialanate (BAY 1067197)

Overview

Phase: Phase 1
Intervention: Neladenoson bialanate (BAY 1067197)
Conditions: Pharmacology, Clinical
Sponsor: Bayer
Enrollment: 22
Locations: 1
Primary Endpoint: AUC for BAY 84-3174
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 24, 2017

End Date

December 17, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

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)