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Last Updated: May 28, 2020

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CLINICAL TRIALS PROFILE FOR DAROLUTAMIDE

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All Clinical Trials for darolutamide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03237416 Drug-drug-interaction Study to Assess the Effect of Darolutamide on the Pharmacokinetics of Probe Substrates of CYP3A4 and P-gp in Healthy Male Volunteers Not yet recruiting Orion Corporation, Orion Pharma Phase 1 2017-08-02 Evaluate the effect of darolutamide on the pharmacokinetics of a probe CYP3A4 substrate and Pgp substrate
NCT03237416 Drug-drug-interaction Study to Assess the Effect of Darolutamide on the Pharmacokinetics of Probe Substrates of CYP3A4 and P-gp in Healthy Male Volunteers Not yet recruiting Bayer Phase 1 2017-08-02 Evaluate the effect of darolutamide on the pharmacokinetics of a probe CYP3A4 substrate and Pgp substrate
NCT03704519 Imaging Study to Compare Effects of Darolutamide and Enzalutamide With Respect to Placebo on the Blood Flow in the Brain in Healthy Male Volunteers. Not yet recruiting Bayer Phase 1 2018-10-15 The current study will 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 is an indirect measure of brain penetration. The risk of drug-associated CNS-related adverse events is 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 is much lower. The aim of this study is to determine whether there is a difference between darolutamide and enzalutamide compared to placebo in cerebral blood flow and thus in brain penetration.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for darolutamide

Condition Name

Condition Name for darolutamide
Intervention Trials
Prostate Cancer 3
Metastatic Castration-resistant Prostate Cancer 2
Cerebrovascular Circulation 1
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Condition MeSH

Condition MeSH for darolutamide
Intervention Trials
Prostatic Neoplasms 8
Prostatic Neoplasms, Castration-Resistant 1
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Clinical Trial Locations for darolutamide

Trials by Country

Trials by Country for darolutamide
Location Trials
United States 3
United Kingdom 1
Germany 1
Canada 1
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Trials by US State

Trials by US State for darolutamide
Location Trials
South Carolina 1
Massachusetts 1
Louisiana 1
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Clinical Trial Progress for darolutamide

Clinical Trial Phase

Clinical Trial Phase for darolutamide
Clinical Trial Phase Trials
Phase 3 2
Phase 2 5
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for darolutamide
Clinical Trial Phase Trials
Not yet recruiting 9
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Clinical Trial Sponsors for darolutamide

Sponsor Name

Sponsor Name for darolutamide
Sponsor Trials
Bayer 7
MANA RBM 1
Jodi Layton, MD 1
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Sponsor Type

Sponsor Type for darolutamide
Sponsor Trials
Other 13
Industry 10
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