Actively Recruiting
Phase 1 Study Using PET Imaging to Measure How MSP-2020 Binds to Serotonin 5-HT2A Receptors in Healthy Men Aged 23 to 55
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2026-06-12
18
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well MSP-2020, a study drug, attaches to serotonin type 2A receptors in the brain of healthy male adults. This Phase 1 study aims to understand the drugs presence in the blood, how long it stays, and its safety profile. The study is conducted by Otsuka Pharmaceutical Development & Commercialization, Inc. and focuses on healthy volunteers aged 23 to 55 years. Participants will receive a single oral dose of MSP-2020 on Day 1. The study uses positron emission tomography PET scans to measure receptor occupancy and drug binding. Blood samples will be collected up to Day 2 to analyze the drugs concentration, peak levels, half-life, and metabolite presence. Safety will be monitored through assessments including vital signs, ECG, laboratory tests, and neurological exams. During the study, participants will stay in a clinical research unit for up to 4 days for observation and assessments. Researchers will monitor adverse events and changes in health status up to Day 15. The primary outcomes focus on drug binding in the brain and pharmacokinetics, while secondary outcomes include safety measures and changes in relevant clinical scales. The total participation time includes dosing, imaging, blood sampling, and safety follow-up.
CONDITIONS
Brief Title
A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to stay in the clinical research unit for up to 4 days
- Body mass index (BMI) between 18.0 to 32.0 kg/m2 inclusive
- In good health based on medical history, physical and neurological exams, medications, ECG, echocardiogram, and laboratory tests including HIV, hepatitis B and C screening
You will not qualify if you...
- First-degree relatives with schizophrenia-spectrum, psychotic, or bipolar disorders
- Allergy to tracer [11C]CIMBI-36
- MRI incompatibility due to implants, claustrophobia, metal fragments, or inability to lie still
- Pathological MRI findings preventing participation
- Prior radiation exposure exceeding 10 mSv within 12 months before first PET scan
- Negative modified Allen test at screening
- Contraindications to radial arterial cannula such as infections, absent pulse, or abnormal coagulation
- Significant medical history or abnormalities that increase risk or affect drug absorption or metabolism
- History of alcohol or substance use disorder within 24 months or weekly alcohol intake over 21 units, and inability to abstain from alcohol from 48 hours before screening until Day 2 discharge
Research Team
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Otsuka Call Center
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