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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: ORM-12741; Drug: Placebo

• Registration Number: NCT03440021
• Lead Sponsor: University of Cape Town

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-20
• Study Start: 2018-03-26
• Primary Completion: 2018-12-05
• Study Completion: 2018-12-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dosage (10mg) ORM-12741	ORM-12741	1 x 10 mg ORM-12741 immediate release capsules and 5 x placebo capsules in a single dose
Placebo	Placebo	6 x placebo capsules in a single dose
High-dosage (60mg) ORM-12741	ORM-12741	6 x 10 mg ORM-12741 immediate release capsules in a single dose

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Effect of ORM-12741 on memory task performance (as measured by accuracy and response latency)	1-3 hours post medication intake
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

Trial Locations

Locations (1)

UCT Dept. Psychiatry & Mental Health / CUBIC; 🇿🇦 Cape Town, Western Cape, South Africa