A Study to Assess Serotonin Transporter Occupancy of Healthy Adults Using 11C-DASB PET

NCT06476509 | Completed Phase 1

• 1 other identifier: LV232-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a non-randomized, open-label clinical study to assess Serotonin transporter occupancy in the brain of healthy adults using 11C-DASB positron emission tomography (PET)

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Serotonin Transporters occupancy

  Percentage of Serotonin Transporters Occupancy in Human Brain after oral LV232 capsule

  baseline and 3 hours after administration on Day 1

Secondary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs).

  Up to Day 7

Study Arms (2)

LV232

EXPERIMENTAL

A single oral dose of 40mg LV232 (5 mg/capsule, 8 capsules each time) ，administrated in fasting state, with 240 mL water to take A single oral dose of 60mg LV232 (5 mg/capsule, 12 capsules each time) ，administrated in fasting state, with 240 mL water to take A single oral dose of 20mg LV232 (5 mg/capsule, 4 capsules each time) ，administrated in fasting state, with 240 mL water to take

Drug: LV232 40mg; Drug: LV232 60mg; Drug: LV232 20mg

Escitalopram

ACTIVE COMPARATOR

A single oral dose of 20mg Escitalopram (10 mg/tablet, 2 tablets each time) , administrated with 240 mL water

Drug: Escitalopram 20 mg

Interventions

LV232 40mg DRUG

oral

Also known as: LV232

LV232

Escitalopram 20 mg DRUG

oral

Also known as: Escitalopram

Escitalopram

LV232 60mg DRUG

oral

Also known as: LV232

LV232

LV232 20mg DRUG

oral

Also known as: LV232

LV232

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Those who voluntarily participate in and sign the informed consent form after understanding the purpose, content, process and possible risks of the trial;
• Male and female, aged 18 to 45 years at the time of signing the informed consent form;
• Body weight, male≥ 50.0 kg ,female≥ 45.0 kg ,and body mass index (BMI) 19.0 \~ 26.0 kg/m2 (including the boundary value) at screening;
• Able to maintain good communication with the investigator and comply with the lifestyle restrictions specified in the protocol and various requirements of the clinical trial (scheduled visits, laboratory tests and other trial procedures);
• Subjects and their partners must use effective non-pharmacological contraception (e.g., abstinence and condom with intravaginal spermicide) throughout the study and for 6 months after the end of the study, and must not donate sperm.

You may not qualify if:

• Known to have a history of allergy to any component of the investigational product or similar drugs, or allergic constitution (previous allergy to two or more foods or drugs);
• The subject with skin diseases or has a history of skin allergies;
• The subject has a current or past medical history judged by the investigator that may affect the clinical trial or dysfunction, including but not limited to a past or present central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc. that require medical intervention or other diseases that are not suitable for clinical trials (such as a history of mental illness);
• Individuals with a history of epileptic seizures, or those with any (acute or chronic) history of mental illness and family history of mental illness, or those with a history of neurodegenerative diseases and family history of neurodegenerative diseases, such as Alzheimer's disease;
• Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial; such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding, etc.;
• Abnormal vital signs (resting pulse rate\<55 beats/minute or\>100 beats/minute; Systolic blood pressure\<90 mmHg or ≥ 140 mmHg; Diastolic blood pressure\<60 mmHg or ≥ 90 mmHg), laboratory tests (blood routine , blood biochemistry, urine routine, thyroid Function), 12 electrocardiogram (ECG, male QTcF\>450 ms，female QTcF\>460 ms), MRI (magnetic resonance imaging) examination indicators, judged by the investigator as abnormal and clinically significant;
• Use of any prescription medication within 28 days prior to dosing; Use of any over-the-counter medications, including health products, within 7 days prior to dosing; Receipt of any contrast agent or radiopharmaceutical within 7 days prior to, or application of contrast agent within 24 hours after, administration of the trial drug;
• Contraindications to PET or MRI (magnetic resonance imaging) (including claustrophobia, alcohol allergy, cardiac pacemaker and nerve stimulator in the body, metal foreign body in the body or tracer component allergy, etc.);
• Any positive result of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab) and Toluidine red unheated serum test (Trust);
• Smoking habit (an average daily smoking of ≥ 5 cigarettes per day within 3 months before administration), drinking habit (an average weekly drinking of more than 14 standard units within 3 months before administration, 1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine). Subjects who cannot quit smoking or drinking in clinical trials.
• Individuals who have a history of drug dependence (including drug use) within one year prior to administration, or who have tested positive for urinary drug abuse screening (benzodiazepines, cocaine, methamphetamine, amphetamine, methadone, tetrahydrocannabinol acid, barbiturates, morphine, phencyclidine, tricyclic antidepressants);
• Those who have special requirements for food and cannot abide by the unified diet or have dysphagia;
• Consumption of xanthine-rich foods or beverages (e.g., tea, coffee, cola, or chocolate) or foods or beverages containing grapefruit and/or pomelo within 3 days before dosing;
• Significant occupational exposure to ionizing radiation (e.g., more than 50 millivolts per year) or exposure to radioactive substances or ionizing radiation for therapeutic or research purposes within the past year;
• Blood donation or blood loss ≥ 400 mL within 3 months before administration, or blood donation or blood loss ≥ 200 mL within one month;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Shanghai Mental Health Center Ethics Committee

Shanghai, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yifeng SHEN, MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 26, 2024
• Study Start: May 30, 2024
• Primary Completion: January 19, 2025
• Study Completion: May 23, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)