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NCT04320771

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

Terminated Phase 1 Last updated 26 March 2020
What this trial tests

Phase 1 trial testing Neladenoson bialanate (BAY 1067197) in Pharmacology, Clinical in 18 participants. Terminated before completion.

Timeline
2 November 2017
Primary endpoint
8 August 2018
17 December 2018

Quick facts

Lead sponsorBayer
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment18
Start date2 November 2017
Primary completion8 August 2018
Estimated completion17 December 2018
Sites2 locations across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 79, any sex, with Pharmacology, Clinical. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Adenosine receptors as promising targets for the management of ocular diseases.
    Spinozzi E, Baldassarri C, Acquaticci L, Del Bello F, et al · · 2021 · cited 13× · PMID 33519168 · DOI 10.1007/s00044-021-02704-x

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Data sources for this page

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