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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age23-55
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MSP-2020

    Drug

    capsule

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: MSP-2020 Oral AdministrationExperimental treatment 1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

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