NCT03704519 is a Phase 1 clinical trial of Darolutamide (BAY1841788) in Cerebrovascular Circulation, sponsored by Bayer.

Who is sponsoring NCT03704519?

NCT03704519 is sponsored by Bayer.

What drugs are being tested in NCT03704519?

Interventions in NCT03704519: Darolutamide (BAY1841788), Enzalutamide, Placebo.

What condition does NCT03704519 study?

NCT03704519 studies Cerebrovascular Circulation.

Is NCT03704519 still recruiting?

NCT03704519 is currently completed. Last updated 30 October 2020.

Last reviewed 2020-10-30 · How we verify

NCT03704519

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

Imaging Study to Compare Effects of Darolutamide and Enzalutamide With Respect to Placebo on the Blood Flow in the Brain in Healthy Male Volunteers.

Completed Phase 1 Last updated 30 October 2020

What this trial tests

Phase 1 trial testing Darolutamide (BAY1841788) in Cerebrovascular Circulation in 26 participants. Completed in 5 November 2019.

Timeline

23 October 2018

Primary endpoint
1 October 2019

5 November 2019

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	26
Start date	23 October 2018
Primary completion	1 October 2019
Estimated completion	5 November 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

Darolutamide (BAY1841788) — full drug profile →
Enzalutamide (enzalutamide) — full drug profile →
Placebo

Conditions studied

Cerebrovascular Circulation — all drugs for Cerebrovascular Circulation →

Sponsor

Bayer — full company profile →

Who can join

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

Sponsor's own description

The current study would investigate the effects of a single dose of darolutamide and enzalutamide compared with placebo and compared to each other on human brain blood flow using arterial spin labeling magnetic resonance imaging (ASL-MRI), a non-invasive MRI technique. The change in cerebral blood flow was an indirect measure of brain penetration. The risk of drug-associated CNS-related adverse events was likely to be correlated with the concentration of the drug in the brain. In contrast to enzalutamide, preclinical studies of darolutamide indicate that its brain penetration was much lower. The aim of this study was to determine whether there was a difference between darolutamide and enzalutamide compared to placebo in cerebral blood flow and thus in brain penetration.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Comparison of Cerebral Blood Flow in Regions Relevant to Cognition After Enzalutamide, Darolutamide, and Placebo in Healthy Volunteers: A Randomized Crossover Trial.
Williams SCR, Mazibuko N, O'Daly O, Zurth C, et al · · 2023 · cited 19× · PMID 37103658 · DOI 10.1007/s11523-023-00959-5
Assessment and Management of Cognitive Function in Patients with Prostate Cancer Treated with Second-Generation Androgen Receptor Pathway Inhibitors.
Wefel JS, Ryan CJ, Van J, Jackson JC, et al · · 2022 · cited 9× · PMID 35522374 · DOI 10.1007/s40263-022-00913-5

Verify or expand the search:

Other recruiting trials for Cerebrovascular Circulation

Currently open trials in the same condition.

NCT07377162 — HYPER MIND - Hyperoxia Effects on Cerebral Hemodynamics · NA · recruiting
NCT06368635 — The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study · recruiting
NCT05051397 — CO2 Modulation in Endovascular Thrombectomy for Acute Ischemic Stroke · Phase 2 · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
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 NCT03704519 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 30 October 2020

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/NCT03704519.

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