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NCT Number: NCT07329621

A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults

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.

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Key information

Conditions

Age range

23 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

HMR Hammersmith Medicines Research Ltd.

London, United Kingdom

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • History of alcohol and/or substance use disorder within the last 24 months according to the Diagnostic Statistical Manual of Mental Disorders and in past medical history or in the investigator's opinion, or intake of > 21 units of alcohol weekly, and the inability to refrain from alcohol use from 48 hours before screening and within 72 hours prior to dosing until discharge from the CRU on Day 2. One unit is equivalent to 1 (25 mL) measure of 40% spirits. For reference, one 330 mL bottle of 5% beer contains 1.7 units and a standard (175 mL) glass of 12% wine contains 2.1 units.

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Treatment and study plan

MSP-2020

Drug

capsule

Primary outcomes

  1. Percent Change in Specific Binding of [11C]CIMBI-36 from Baseline and EC50 Using Cortical Regions [11C]CIMBI-36 BPND

    Time frame: Up to Day 2

  2. PK Plasma Concentration of MSP-2020 and its Metabolite

    Time frame: Up to Day 2

  3. Maximum (peak) Plasma Concentration of MSP-2020 and its Metabolite

    Time frame: Up to Day 2

  4. Time to Maximum (peak) Plasma Concentration of MSP-2020 and its Metabolite

    Time frame: Up to Day 2

  5. Half-life (t1/2) of MSP-2020 and its metabolite

    Time frame: Up to Day 2

  6. Area under the concentration-time curve (AUCt) of MSP-2020 and its metabolite

    Time frame: Up to Day 2

Secondary outcomes

  1. Change from baseline in relevant scales

    Time frame: Up to Day 2

  2. Concentration of the metabolite at which 50% of the 5-HT2A receptors are occupied, as measured by PET imaging

    Time frame: Up to Day 2

  3. Number of Participants With Adverse Events (AEs)

    Time frame: Up to Day 15

  4. Number of Participants With Potentially Clinically Significant Changes in Vital Signs

    Time frame: Up to Day 2

  5. Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG)

    Time frame: Up to Day 2

  6. Number of Participants With Potentially Clinically Significant Changes in Laboratory Tests

    Time frame: Up to Day 15

  7. Number of Participants With Potentially Clinically Significant Changes in Physical and Neurological Examinations

    Time frame: Up to Day 15

  8. Number of Participants With Suicidality on Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to Day 15

Study contacts

Contact information is provided by the study sponsor or research team.

Otsuka Call Center

CONTACT

[email protected]

844-687-8522

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-label, Positron Emission Tomography (PET) Trial to Measure Serotonin 5-HT2A Receptor Occupancy Following Single Oral Doses of MSP-2020 in Healthy Male Adults

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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