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Can a new drug avoid the high? soticlestat put to the test

NCT ID NCT05602818

Knowledge-focused Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether soticlestat, an experimental drug, has the potential to be abused. The study enrolls about 100 healthy adults who have used central nervous system depressants for recreational reasons. Participants receive different doses of soticlestat, a comparison drug called alprazolam, and a placebo in a random order. They rate how much they like the drug effects, which helps researchers compare soticlestat's abuse potential to a known drug of abuse.

What this could mean

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

Active substance
soticlestat, an experimental drug given at three dose levels
What this could lead to
If soticlestat shows low abuse potential, it could support its development as a treatment with less risk of misuse.
What could go wrong
This is a small, early-phase study in healthy volunteers with recreational drug experience. Its results may not predict how the drug behaves in patients or with long-term use.

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

100 people

The number who actually took part.

Started

Nov 2022

Finished

Jul 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 55 years

Sex

Anyone

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 1. Healthy as determined by the investigator. 2. Current CNS depressant user who has used CNS depressants (example, benzodiazepines, barbiturates, zolpidem, eszopiclone, zopiclone, propofol/fospropofol, gamma-hydroxybutyrate) for recreational, nontherapeutic reasons at least 10 times in their lifetime and at least once in the 12 weeks prior to screening. Participant must also have recreational experience with at least 1 other drug class associated with abuse (example, opioids, stimulants, cannabinoids, hallucinogens, dissociatives) at least 10 times in their lifetime. 3. Body mass index (BMI) of 18.5 to 35.0 kilogram per square meter (kg/m\^2), inclusive, and a minimum body weight of 50.0 Kilogram (kg) at screening. Exclusion Criteria 1. Self-reported history of drug or alcohol dependence (within the past 1 year, except caffeine or nicotine, prior to the screening visit). 2. Positive alcohol breathalyzer or urine drug screen (UDS) for substances of abuse at admission, excluding tetrahydrocannabinol (THC). 3. Heavy smoker or user of other types of nicotine products (greater than \[\>\] 20 cigarettes equivalent per day). 4. Unable to abstain from smoking for at least 2 hours before and at least 8 hours after dosing. 5. Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

Contacts and locations

Locations

  • Altasciences

    Overland Park, Kansas, 66212, United States

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