Single-dose Novel Selective alpha2c Antagonist Pharmaco-MRI Study in Healthy Volunteers

NCT03440021 — Phase 1, Completed, 68 participants, University of Cape Town

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The Effects of Single-dose Administration of a Novel Selective alpha2c Antagonist on Emotional and Cognitive Processing in Healthy Volunteers: an fMRI Investigation

Registry	NCT03440021, acronym SNAP_MRI
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: double, basic science
Enrollment	68 (Actual)
Sponsor	University of Cape Town (Other); collaborators: Orion Corporation, Orion Pharma, University of Oxford
Conditions	Healthy Volunteer
Interventions	ORM-12741, Placebo (Drug)
Dates	start 2018-03-26, primary completion 2018-12-05, completion 2018-12-06, first posted 2018-02-20, last updated 2019-01-10
Locations	1 site in South Africa

-Summary

The aim of the present study is to investigate changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with emotional and working memory during task performance after single-dose administration of a novel selective alpha2c adrenoceptor antagonist (ORM-12741) in healthy volunteers. Further, it will be explored whether ORM-12741 affects connectivity between brain areas in rest, as measured using fMRI, and cognitive performance in the sample under investigation.

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+Arms and interventions

Arm	Type	Interventions	Description
High-dosage (60mg) ORM-12741	Experimental	Drug: ORM-12741	6 x 10 mg ORM-12741 immediate release capsules in a single dose
Low-dosage (10mg) ORM-12741	Experimental	Drug: ORM-12741	1 x 10 mg ORM-12741 immediate release capsules and 5 x placebo capsules in a single dose
Placebo	Placebo comparator	Drug: Placebo	6 x placebo capsules in a single dose

ORM-12741 (Drug): Novel selective alpha2c adrenoceptor antagonist
Placebo (Drug): Identical in appearance to experimental drug, not psycho-active

+Outcome measures

Primary outcomes

Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with emotional memory [1-1.5 hours post medication intake]
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with working memory [1-1.5 hours post medication intake]

Secondary outcomes

Effect of ORM-12741 on connectivity measures between brain areas as measured with BOLD signal in fMRI obtained in a resting state [1.5-2 hours post medication intake]
Effect of ORM-12741 on memory task performance (as measured by accuracy and response latency) [1-3 hours post medication intake]

+Eligibility

Sex: All, ages: 18 Years to 30 Years, accepts healthy volunteers

Inclusion Criteria:

* good command of English language
* right handedness
* normal or corrected-to-normal vision

Exclusion Criteria:

* personal history or active presence of psychiatric conditions
* usage of psychotropic medication within the past 3 months
* pregnancy or breast-feeding status
* systolic blood pressure < 90 mmHg or > 140 mmHg at screening visit
* diastolic blood pressure < 50 mmHg or > 90 mmHg at screening visit
* resting heart rate < 45 beats/minute or > 100 beats/minute at screening visit
* active presence of medical condition at physical examination
* history of major traumatic brain injury
* any other contraindication to MRI of the brain
* use of psychoactive substances incl. alcohol in 24 hours prior to test session

+Locations (1)

Facility	City	Country	Status
UCT Dept. Psychiatry & Mental Health / CUBIC	Cape Town, Western Cape	South Africa

+Investigators

Dan J. Stein, MD, PhD, Principal investigator, University of Cape Town

My Notes

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