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

University of Cape Town (UCT)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ORM-12741; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03440021

DOH-27-0218-5843 (Registry Identifier)

N2/19/8/2 (Other Identifier)

069/2017

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 3 patient groups, including a placebo group

High-dosage (60mg) ORM-12741

Experimental group

Description:

6 x 10 mg ORM-12741 immediate release capsules in a single dose

Treatment:

Drug: ORM-12741

Low-dosage (10mg) ORM-12741

Experimental group

Description:

1 x 10 mg ORM-12741 immediate release capsules and 5 x placebo capsules in a single dose

Treatment:

Drug: ORM-12741

Placebo

Placebo Comparator group

Description:

6 x placebo capsules in a single dose

Treatment:

Drug: Placebo