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Trial record 43 of 58495 for:    Placebo

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

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ClinicalTrials.gov Identifier: NCT03704519
Recruitment Status : Active, not recruiting
First Posted : October 12, 2018
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cerebrovascular Circulation Drug: Darolutamide (BAY1841788) Drug: Enzalutamide Other: Placebo Phase 1

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I, Randomized, Placebo-controlled, Open-label, Three Period Crossover Study to Investigate the Effect of Darolutamide and Enzalutamide on Cerebral Blood Flow in Healthy Male Volunteers.
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : August 20, 2019
Estimated Study Completion Date : September 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Men_EPD
Healthy male participants receive drugs in order Enzalutamide, Placebo and Darolutamide.
Drug: Darolutamide (BAY1841788)
300 mg tablet darolutamide, once orally
Other Name: Darolutamide: ODM-201

Drug: Enzalutamide
4 x 40 mg capsules, once orally
Other Name: MDV3100

Other: Placebo
4 placebo tablets, once orally
Other Name: Darolutamide-matching placebo

Experimental: Men_DEP
Healthy male participants receive drugs in order Darolutamide, Enzalutamide and Placebo.
Drug: Darolutamide (BAY1841788)
300 mg tablet darolutamide, once orally
Other Name: Darolutamide: ODM-201

Drug: Enzalutamide
4 x 40 mg capsules, once orally
Other Name: MDV3100

Other: Placebo
4 placebo tablets, once orally
Other Name: Darolutamide-matching placebo

Experimental: Men_PDE
Healthy male participants receive drugs in order Placebo, Darolutamide and Enzalutamide.
Drug: Darolutamide (BAY1841788)
300 mg tablet darolutamide, once orally
Other Name: Darolutamide: ODM-201

Drug: Enzalutamide
4 x 40 mg capsules, once orally
Other Name: MDV3100

Other: Placebo
4 placebo tablets, once orally
Other Name: Darolutamide-matching placebo

Experimental: Men_DPE
Healthy male participants receive drugs in order Darolutamide, Placebo and Enzalutamide.
Drug: Darolutamide (BAY1841788)
300 mg tablet darolutamide, once orally
Other Name: Darolutamide: ODM-201

Drug: Enzalutamide
4 x 40 mg capsules, once orally
Other Name: MDV3100

Other: Placebo
4 placebo tablets, once orally
Other Name: Darolutamide-matching placebo

Experimental: Men_EDP
Healthy male participants receive drugs in order Enzalutamide, Darolutamide and Placebo.
Drug: Darolutamide (BAY1841788)
300 mg tablet darolutamide, once orally
Other Name: Darolutamide: ODM-201

Drug: Enzalutamide
4 x 40 mg capsules, once orally
Other Name: MDV3100

Other: Placebo
4 placebo tablets, once orally
Other Name: Darolutamide-matching placebo

Experimental: Men_PED
Healthy male participants receive drugs in order Placebo, Enzalutamide and Darolutamide.
Drug: Darolutamide (BAY1841788)
300 mg tablet darolutamide, once orally
Other Name: Darolutamide: ODM-201

Drug: Enzalutamide
4 x 40 mg capsules, once orally
Other Name: MDV3100

Other: Placebo
4 placebo tablets, once orally
Other Name: Darolutamide-matching placebo




Primary Outcome Measures :
  1. Change in grey-matter cerebral blood flow of enzalutamide as compared to placebo [ Time Frame: At 4 hours after drug ]
    Obtained by comparing whole brain grey matter quantitative voxel-by-voxel maps of cerebral blood flow/ perfusion (mL per 100g tissue per min) of enzalutamide to placebo. Measured in grey matter voxels with arterial spin labeling magnetic resonance imaging (ASL-MRI).

  2. Change in grey-matter cerebral blood flow of darolutamide as compared to placebo [ Time Frame: At 4 hours after drug ]
    Obtained by comparing whole brain grey matter quantitative voxel-by-voxel maps of cerebral blood flow/ perfusion (mL per 100g tissue per min) of darolutamide to placebo. Measured in grey matter voxels with ASL-MRI.

  3. Change in grey-matter cerebral blood flow of enzalutamide as compared to darolutamide [ Time Frame: At 4 hours after drug ]
    Obtained by comparing whole brain grey matter quantitative voxel-by-voxel maps of cerebral blood flow/ perfusion (mL per 100g tissue per min) of enzalutamide to darolutamide. Measured in grey matter voxels with ASL-MRI.


Secondary Outcome Measures :
  1. Change in mean regional grey-matter cerebral blood flow in brain areas related to cognitive function during treatment of enzalutamide as compared to placebo [ Time Frame: At 4 hours after drug ]
    Brain areas related to cognitive function comprise hippocampus and frontal cortex. Cerebral blood flow measured with ASL-MRI.

  2. Change in mean regional grey-matter cerebral blood flow in brain areas related to cognitive function during treatment of darolutamide as compared to placebo [ Time Frame: At 4 hours after drug ]
    Brain areas related to cognitive function comprise hippocampus and frontal cortex. Cerebral blood flow measured with ASL-MRI.

  3. Change in mean regional grey-matter cerebral blood flow in brain areas related to cognitive function during treatment of enzalutamide as compared to darolutamide [ Time Frame: At 4 hours after drug ]
    Brain areas related to cognitive function comprise hippocampus and frontal cortex. Cerebral blood flow measured with ASL-MRI.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704519


Locations
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United Kingdom
Academic Neuroscience Centre, Kings College
London, United Kingdom, SE5 8AF
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03704519     History of Changes
Other Study ID Numbers: 18426
2018-001599-39 ( EudraCT Number )
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Healthy volunteers
Magnetic Resonance Imaging (MRI)