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

NCT ID: NCT03704519

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-23

Study Completion Date

2019-11-05

Brief Summary

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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.

Detailed Description

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The primary objective was to investigate drug-induced changes in grey matter cerebral blood flow during single-dose treatment with darolutamide or enzalutamide as compared to placebo using voxel-wise quantification of the grey matter for the entire brain.

The secondary objective was to investigate drug-induced changes in regional cerebral blood flow in brain areas related to cognitive function after single-dose treatment.

Conditions

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Cerebrovascular Circulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Men_EPD

Healthy male participants receive drugs in order Enzalutamide, Placebo and Darolutamide.

Group Type EXPERIMENTAL

Darolutamide (BAY1841788)

Intervention Type DRUG

300 mg tablet darolutamide, once orally

Enzalutamide

Intervention Type DRUG

4 x 40 mg capsules, once orally

Placebo

Intervention Type OTHER

4 placebo tablets, once orally

Men_DEP

Healthy male participants receive drugs in order Darolutamide, Enzalutamide and Placebo.

Group Type EXPERIMENTAL

Darolutamide (BAY1841788)

Intervention Type DRUG

300 mg tablet darolutamide, once orally

Enzalutamide

Intervention Type DRUG

4 x 40 mg capsules, once orally

Placebo

Intervention Type OTHER

4 placebo tablets, once orally

Men_PDE

Healthy male participants receive drugs in order Placebo, Darolutamide and Enzalutamide.

Group Type EXPERIMENTAL

Darolutamide (BAY1841788)

Intervention Type DRUG

300 mg tablet darolutamide, once orally

Enzalutamide

Intervention Type DRUG

4 x 40 mg capsules, once orally

Placebo

Intervention Type OTHER

4 placebo tablets, once orally

Men_DPE

Healthy male participants receive drugs in order Darolutamide, Placebo and Enzalutamide.

Group Type EXPERIMENTAL

Darolutamide (BAY1841788)

Intervention Type DRUG

300 mg tablet darolutamide, once orally

Enzalutamide

Intervention Type DRUG

4 x 40 mg capsules, once orally

Placebo

Intervention Type OTHER

4 placebo tablets, once orally

Men_EDP

Healthy male participants receive drugs in order Enzalutamide, Darolutamide and Placebo.

Group Type EXPERIMENTAL

Darolutamide (BAY1841788)

Intervention Type DRUG

300 mg tablet darolutamide, once orally

Enzalutamide

Intervention Type DRUG

4 x 40 mg capsules, once orally

Placebo

Intervention Type OTHER

4 placebo tablets, once orally

Men_PED

Healthy male participants receive drugs in order Placebo, Enzalutamide and Darolutamide.

Group Type EXPERIMENTAL

Darolutamide (BAY1841788)

Intervention Type DRUG

300 mg tablet darolutamide, once orally

Enzalutamide

Intervention Type DRUG

4 x 40 mg capsules, once orally

Placebo

Intervention Type OTHER

4 placebo tablets, once orally

Interventions

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Darolutamide (BAY1841788)

300 mg tablet darolutamide, once orally

Intervention Type DRUG

Enzalutamide

4 x 40 mg capsules, once orally

Intervention Type DRUG

Placebo

4 placebo tablets, once orally

Intervention Type OTHER

Other Intervention Names

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Darolutamide: ODM-201 MDV3100 Darolutamide-matching placebo

Eligibility Criteria

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Inclusion Criteria

* Participants who are healthy as determined by medical history, physical examination, laboratory tests, and cardiac monitoring.

Exclusion Criteria

* Existing or recent relevant diseases of vital organs (eg, liver diseases, heart diseases, renal disease, lung disease), central nervous system or other organs (eg, Diabetes mellitus, myasthenia gravis).
* Known contraindication to magnetic resonance imaging.
* Any structural variants or pathological abnormalities on structural brain MRI during screening.
* Any history of seizures including a febrile seizure in childhood, loss of consciousness, transient ischemic attack, or any condition that may pre-dispose to seizure.
* Participant with any type of neurological problems or history of psychiatric disorder, especially mood disorders including medical history with suicidal ideation and/or suicide attempts, which may disable the participant to consent to the study.
* Participants who use prescription or oral over the counter medications which might influence the study objectives, dietary/nutritional supplements, (including vitamins, natural and herbal remedies, eg, St. John's wort) within 2 weeks prior to first study intervention administration or during the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Centre for Neuroimaging Sciences, King's College

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Williams SCR, Mazibuko N, O'Daly O, Zurth C, Patrick F, Kappeler C, Kuss I, Cole PE. Comparison of Cerebral Blood Flow in Regions Relevant to Cognition After Enzalutamide, Darolutamide, and Placebo in Healthy Volunteers: A Randomized Crossover Trial. Target Oncol. 2023 May;18(3):403-413. doi: 10.1007/s11523-023-00959-5. Epub 2023 Apr 27.

Reference Type DERIVED
PMID: 37103658 (View on PubMed)

Related Links

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http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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2018-001599-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18426

Identifier Type: -

Identifier Source: org_study_id