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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат MSP-2020
  capsule

Первичные конечные точки

• Percent Change in Specific Binding of [11C]CIMBI-36 from Baseline and EC50 Using Cortical Regions [11C]CIMBI-36 BPND [Срок оценки: Up to Day 2]
• PK Plasma Concentration of MSP-2020 and its Metabolite [Срок оценки: Up to Day 2]
• Maximum (peak) Plasma Concentration of MSP-2020 and its Metabolite [Срок оценки: Up to Day 2]
• Time to Maximum (peak) Plasma Concentration of MSP-2020 and its Metabolite [Срок оценки: Up to Day 2]
• Half-life (t1/2) of MSP-2020 and its metabolite [Срок оценки: Up to Day 2]
• Area under the concentration-time curve (AUCt) of MSP-2020 and its metabolite [Срок оценки: Up to Day 2]

Вторичные конечные точки (8)

• Change from baseline in relevant scales [Срок оценки: Up to Day 2]
• Concentration of the metabolite at which 50% of the 5-HT2A receptors are occupied, as measured by PET imaging [Срок оценки: Up to Day 2]
• Number of Participants With Adverse Events (AEs) [Срок оценки: Up to Day 15]
• Number of Participants With Potentially Clinically Significant Changes in Vital Signs [Срок оценки: Up to Day 2]
• Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) [Срок оценки: Up to Day 2]
• Number of Participants With Potentially Clinically Significant Changes in Laboratory Tests [Срок оценки: Up to Day 15]
• Number of Participants With Potentially Clinically Significant Changes in Physical and Neurological Examinations [Срок оценки: Up to Day 15]
• Number of Participants With Suicidality on Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Up to Day 15]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• HMR Hammersmith Medicines Research Ltd. — London

Идентификаторы

NCT: NCT07329621 · 358-201-00002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗