Investigation of Pharmacokinetics, Safety and Tolerability of Neladenoson Bialanate in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight-matched Healthy Subjects Following a Single Oral Dose of 10 mg Neladenoson Bialanate Given as IR Tablet in a Single-center, Nonrandomized, Non-controlled, Non-blinded, Study With Group Stratification

Bayer2 sites in 1 country18 target enrollmentNovember 2, 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: 18
Locations: 2
Primary Endpoint: Cmax 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). 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

Registry

clinicaltrials.gov

Start Date

November 2, 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 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