A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy … (NCT07329621) | Clinical Trial Compass
RecruitingPhase 1
A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults
United Kingdom18 participantsStarted 2026-01-15
Plain-language summary
This study is to see how well MSP-2020 attaches to specific targets in the brain called serotonin type 2A receptors (5-HT2AR). This study will also look at how much of the study drug (and its metabolite) is in the blood and how long the study drug stays in the blood, as well as the safety of MSP 2020.
Who can participate
Age range
23 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to stay in the CRU for up to 4 days.
. Body mass index (BMI) between 18.0 to 32.0 kg/m2 (inclusive).
. In good health as determined by: a. Medical history; b. Physical and neurological examination; c. Concomitant medications; d. ECG; e. Screening echocardiogram; f. Serum chemistry, urinalysis, haematology, coagulation, and serology (HIV screen, HBsAg, and anti-HCV) tests.
Exclusion criteria
. In first-degree relatives, a history of any schizophrenia-spectrum disorder, psychotic disorder, or bipolar and related disorders.
. History of allergy to tracer \[11C\]CIMBI-36.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in Specific Binding of [11C]CIMBI-36 from Baseline and EC50 Using Cortical Regions [11C]CIMBI-36 BPND
Timeframe: Up to Day 2
2
PK Plasma Concentration of MSP-2020 and its Metabolite
Timeframe: Up to Day 2
3
Maximum (peak) Plasma Concentration of MSP-2020 and its Metabolite
Timeframe: Up to Day 2
4
Time to Maximum (peak) Plasma Concentration of MSP-2020 and its Metabolite
Timeframe: Up to Day 2
5
Half-life (t1/2) of MSP-2020 and its metabolite
Timeframe: Up to Day 2
6
Area under the concentration-time curve (AUCt) of MSP-2020 and its metabolite
Timeframe: Up to Day 2
Trial details
NCT IDNCT07329621
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
. MRI incompatibility due to implants including but not limited to pacemaker, artificial joints, or non-removable body piercings, and/or other contraindications for MRI such as claustrophobia, metal objects/fragments, or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals (eg, welding), or have motor problems that prevent the participant from lying still for the MRI.
. Pathological MRI findings that would preclude from trial participation.
. History of prior radiation exposure for research purposes such that participation in this trial would result in an ionising radiation exposure of \> 10 mSv within a year (12 months) of the first PET scan that would cause the participant to exceed the yearly dose limit.
. Have a negative modified Allen test at screening.
. Contraindications to radial arterial cannula (including but not limited to cellulitis or other infections over the radial artery, absence of palpable radial artery pulse, or a clinically significant abnormal coagulation profile).
. Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, haematologic, dermatologic, and immunologic disease.