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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSP-2020 Oral Administration | Experimental | Participants will receive a single dose of MSP-2020 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSP-2020 | Drug | capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Specific Binding of [11C]CIMBI-36 from Baseline and EC50 Using Cortical Regions [11C]CIMBI-36 BPND | Up to Day 2 | |
| PK Plasma Concentration of MSP-2020 and its Metabolite | Up to Day 2 | |
| Maximum (peak) Plasma Concentration of MSP-2020 and its Metabolite | Up to Day 2 | |
| Time to Maximum (peak) Plasma Concentration of MSP-2020 and its Metabolite | Up to Day 2 | |
| Half-life (t1/2) of MSP-2020 and its metabolite | Up to Day 2 | |
| Area under the concentration-time curve (AUCt) of MSP-2020 and its metabolite | Up to Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in relevant scales | Up to Day 2 | |
| Concentration of the metabolite at which 50% of the 5-HT2A receptors are occupied, as measured by PET imaging | Up to Day 2 | |
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Inclusion Criteria
Exclusion Criteria
Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Otsuka Call Center | Contact | 844-687-8522 | Otsuka-ProfessionalServices@otsuka-us.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HMR Hammersmith Medicines Research Ltd. | Recruiting | London | United Kingdom |
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| Label | URL |
|---|---|
| Otsuka Clinical Trial Website | View source |
| Otsuka Clinical Trial Transparency | View source |
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Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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| Number of Participants With Adverse Events (AEs) |
| Up to Day 15 |
| Number of Participants With Potentially Clinically Significant Changes in Vital Signs | Up to Day 2 |
| Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) | Up to Day 2 |
| Number of Participants With Potentially Clinically Significant Changes in Laboratory Tests | Up to Day 15 |
| Number of Participants With Potentially Clinically Significant Changes in Physical and Neurological Examinations | Up to Day 15 |
| Number of Participants With Suicidality on Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Day 15 |