Healthy VolunteerPhase 1SNAP_MRINCT03440021
Single-dose Novel Selective alpha2c Antagonist Pharmaco-MRI Study in Healthy Volunteers
A Phase 1 study testing ORM-12741 in people with Healthy Volunteer, run by University of Cape Town at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ORM-12741
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSouth Africa
- Study dates
- 26 Mar 2018to 6 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good command of English language
- right handedness
- normal or corrected-to-normal vision
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
South Africa1 site
UCT Dept. Psychiatry & Mental Health / CUBIC
Cape Town, Western Cape, 7925
About this study
Official title: The Effects of Single-dose Administration of a Novel Selective alpha2c Antagonist on Emotional and Cognitive Processing in Healthy Volunteers: an fMRI Investigation
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.
- Conditions
- Healthy Volunteer
- Being tested
- ORM-12741, Placebo
- Keywords
- Noradrenalin Agents, Physiological Effects of Drugs, Mood disorders, Behavioral Symptoms
- Medical subject headings
- Mood Disorders, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORM-12741Drug
Novel selective alpha2c adrenoceptor antagonist
PlaceboDrug
Identical in appearance to experimental drug, not psycho-active
| Study group | Role | What they receive |
|---|---|---|
| High-dosage (60mg) ORM-12741 | Experimental | 6 x 10 mg ORM-12741 immediate release capsules in a single dose Receives: Drug: ORM-12741 |
| Low-dosage (10mg) ORM-12741 | Experimental | 1 x 10 mg ORM-12741 immediate release capsules and 5 x placebo capsules in a single dose Receives: Drug: ORM-12741 |
| Placebo | Placebo comparator | 6 x placebo capsules in a single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with emotional memory
Measured: 1-1.5 hours post medication intake
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with working memory
Measured: 1-1.5 hours post medication intake
Secondary outcomes (2)
Effect of ORM-12741 on connectivity measures between brain areas as measured with BOLD signal in fMRI obtained in a resting state
Measured: 1.5-2 hours post medication intake
Effect of ORM-12741 on memory task performance (as measured by accuracy and response latency)
Measured: 1-3 hours post medication intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start26 Mar 2018
- Primary completion5 Dec 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- High-dosage (60mg), Low-dosage (10mg), Placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma, University of Oxford
- Responsible party
- Principal investigator, Prof. Dan J. Stein, University of Cape Town
- Investigators
- Dan J. Stein, MD, PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440021
- Sponsor's protocol ID
- 069/2017
- Other IDs
- N2/19/8/2, DOH-27-0218-5843
- Acronym
- SNAP_MRI
- Status last verified
- Jan 2019
- First submitted
- 13 Feb 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Single-dose Administration of a Novel Selective alpha2c Antagonist on Emotional and Cognitive Processing in Healthy Volunteers: an fMRI Investigation
- ClinicalTrials.gov ID
- NCT03440021
- Acronym / sponsor ID
- SNAP_MRI / 069/2017
- Conditions
- Healthy Volunteer
- Keywords
- Noradrenalin Agents, Physiological Effects of Drugs, Mood disorders, Behavioral Symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma, University of Oxford
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- High-dosage (60mg), Low-dosage (10mg), Placebo
| Arm | Type | Receives |
|---|---|---|
| High-dosage (60mg) ORM-12741 | Experimental | Drug: ORM-127416 x 10 mg ORM-12741 immediate release capsules in a single dose |
| Low-dosage (10mg) ORM-12741 | Experimental | Drug: ORM-127411 x 10 mg ORM-12741 immediate release capsules and 5 x placebo capsules in a single dose |
| Placebo | Placebo comparator | Drug: Placebo6 x placebo capsules in a single dose |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- good command of English language
- right handedness
- normal or corrected-to-normal vision
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORM-12741Novel selective alpha2c adrenoceptor antagonist | Drug | High-dosage (60mg) ORM-12741, Low-dosage (10mg) ORM-12741 |
| PlaceboIdentical in appearance to experimental drug, not psycho-active | Drug | Placebo |
Primary outcome
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with emotional memory
Time frame: 1-1.5 hours post medication intake
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with working memory
Time frame: 1-1.5 hours post medication intake
2 secondary outcomes
Effect of ORM-12741 on connectivity measures between brain areas as measured with BOLD signal in fMRI obtained in a resting state
Time frame: 1.5-2 hours post medication intake
Effect of ORM-12741 on memory task performance (as measured by accuracy and response latency)
Time frame: 1-3 hours post medication intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan J. Stein, MD, PhD principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ORM-12741 in people with Healthy Volunteer, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with emotional memory (time frame: 1-1.5 hours post medication intake). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.