Brain scans reveal how experimental drug LG-0317 targets serotonin transporters

NCT ID NCT07708428

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This early-phase study uses PET/CT brain scans to see how much of a single dose of LG-0317 tablets binds to serotonin transporters (SERT) in the brains of healthy men aged 18 to 45. Researchers will also measure drug levels in the blood and monitor for side effects. The goal is to understand the relationship between dose, brain occupancy, and safety before testing the drug in people with medical conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LG-0317 tablets
What this could lead to
If successful, this study could help determine the right dose of LG-0317 for future trials targeting conditions linked to serotonin, such as depression or anxiety.
What could go wrong
This is a very early, small study in healthy volunteers, so results may not predict effects in patients. The drug may also cause side effects not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Healthy male subjects age 18 to 45 years of age included. * Participant must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 19-28 kg/m2 inclusive. * The participant has normal results or abnormalities without clinical significance as judged by the investigator for vital signs, physical examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis), 12-lead electrocardiogram (ECG. * Fully understand the trial content, procedures, and possible adverse reactions; voluntarily participate and sign the informed consent form (ICF). * Able to communicate well with the study personnel, and understand and comply with the relevant requirements of the trial. Exclusion Criteria: * 1\) Allergic constitution, history of allergic diseases, or known allergy to the investigational product, its excipients, or related products. 2\) History of current or prior neurological disorders, including but not limited to: history of head trauma or concussion; history of stroke or known cerebrovascular diseases (e.g., intracranial aneurysm, arteriovenous malformation); or other known structural abnormalities of the brain. 3\) History of serious unstable diseases or related medical history affecting the hepatic, renal, gastrointestinal, endocrine, cardiovascular (including known aneurysmal vascular lesions), metabolic, hematological, respiratory, or autoimmune systems. 4\) History of psychiatric disorders, substance abuse, or drug dependence. 5) Presence of epileptiform abnormalities (EAs) on screening electroencephalogram (EEG). (Screening EEG will include hyperventilation and intermittent photic stimulation as activation procedures.) 6) Personal history of epilepsy or family history of epilepsy in first-degree relatives (i.e., parents, siblings, or children). 7\) Suicidal risk as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS); specifically, if the participant answers "yes" to Question 4 or 5 of the Suicidal Ideation section of the C-SSRS during screening and the most recent intent or plan occurred within the past 6 months; or answers "yes" to any question in the Suicidal Behavior section occurring within the past 2 years; or deemed at suicidal risk based on the investigator's clinical judgment. 8\) Any relevant history of illness, surgery, or trauma within 3 months prior to the first dose that could affect safety or pharmacokinetics, or planned surgery during the study period. 9\) Inability to swallow tablets. 10) Difficult venous access, intolerance to venipuncture/indwelling catheters, or history of vasovagal syncope (fainting) related to needles/blood (needle-phobia or hemophobia). 11\) Excessive consumption (\>8 cups/day; 1 cup = 250 mL) of tea, coffee, or caffeinated beverages within 3 months prior to screening; or consumption of chocolate, caffeine-containing products, alcohol, grapefruit/grapefruit juice, or xanthine-rich foods/beverages within 48 hours prior to the first dose. 12\) Alcohol consumption exceeding 21 standard units per week within 3 months prior to screening (1 standard unit contains 14 g of alcohol, e.g., 360 mL beer, 45 mL liquor at 40% alcohol, or 150 mL wine); or positive result on breath alcohol testing. 13\) Smoking history ≥5 cigarettes per day within 3 months prior to screening. 14) Use of any prescription drugs, over-the-counter medications, herbal remedies, or dietary supplements within 14 days prior to the first dose. 15\) Participation in another clinical trial involving investigational product within 3 months prior to the first dose. 16\) Blood donation or significant blood loss (\>400 mL), or receipt of blood transfusion within 3 months prior to the first dose. 17\) Participation in a clinical study involving radiation exposure within the past 12 months, or receipt of significant diagnostic/therapeutic radiation exposure for medical reasons within the past 12 months, leading to an estimated cumulative annual radiation dose exceeding safety limits (e.g., ≥10 mSv) based on ICRP recommendations. 18\) Any contraindication to PET/CT or MRI scanning, including but not limited to: presence of implanted metallic objects (e.g., cardiac pacemaker, metal prosthesis, implanted neurostimulator); claustrophobia; or body habitus/weight unsuitable for the PET/CT or MRI scanner bore. Note: Contraindications identified during any prior MRI scan or the baseline MRI conducted prior to the screening PET/CT scan also apply. 19\) Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (syphilis). 20\) Use of illicit drugs within 3 months prior to screening or positive urine drug screen (including morphine, methamphetamine, methadone, phencyclidine \[PCP\], tetrahydrocannabinol carboxylic acid \[THC-COOH\], amphetamine, cocaine, barbiturates, benzodiazepines, ketamine, tricyclic antidepressants). 21\) Plan to conceive, donate sperm, or unwillingness to use effective contraception during the study and for 3 months after the last dose. 22\) Known photosensitive disorder or history of abnormal sensitivity to sunlight. 23\) Affiliation with the study site staff, employment by the sponsor, or being an immediate family member of such personnel. 24\) Any other condition that, in the investigator's opinion, makes the participant unsuitable for inclusion in the study.

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