NCT02957396 is a Phase 1 clinical trial of Finerenone (BAY94-8862): 20 mg intact tablet in Pharmacokinetics, sponsored by Bayer.

Who is sponsoring NCT02957396?

NCT02957396 is sponsored by Bayer.

What drugs are being tested in NCT02957396?

Interventions in NCT02957396: Finerenone (BAY94-8862): 20 mg intact tablet, Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet, Finerenone (BAY94-8862): 20 mg suspension.

What condition does NCT02957396 study?

NCT02957396 studies Pharmacokinetics.

Is NCT02957396 still recruiting?

NCT02957396 is currently completed. Last updated 24 April 2017.

Last reviewed 2017-04-24 · How we verify

NCT02957396

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects

Completed Phase 1 Last updated 24 April 2017

What this trial tests

Phase 1 trial testing Finerenone (BAY94-8862): 20 mg intact tablet in Pharmacokinetics in 16 participants. Completed in 1 March 2017.

Timeline

17 November 2016

Primary endpoint
13 January 2017

1 March 2017

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	16
Start date	17 November 2016
Primary completion	13 January 2017
Estimated completion	1 March 2017
Sites	1 location across Germany

Drugs / interventions tested

Finerenone (BAY94-8862): 20 mg intact tablet — full drug profile →
Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet — full drug profile →
Finerenone (BAY94-8862): 20 mg suspension — full drug profile →

Conditions studied

Pharmacokinetics — all drugs for Pharmacokinetics →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 45, male only, with Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a novel liquid formulation for the treatment of children in comparison to the adult tablet formulation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Bayer trials

Trials by the same sponsor.

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NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02957396 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 24 April 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02957396.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing