Healthy VolunteersPhase 1NCT05602818

A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience

A Phase 1 study testing Soticlestat 300 mg, Soticlestat 600 mg and Soticlestat 900 mg in people with Healthy Volunteers, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main aim is to evaluate the relative abuse potential of soticlestat in healthy adults who has used central nervous system (CNS) depressants for recreational nontherapeutic reasons. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Soticlestat 300 mg, Soticlestat 600 mg and Soticlestat 900 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2022to 7 Jul 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy as determined by the investigator.
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.
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.

Who cannot join

Self-reported history of drug or alcohol dependence (within the past 1 year, except caffeine or nicotine, prior to the screening visit).
Positive alcohol breathalyzer or urine drug screen (UDS) for substances of abuse at admission, excluding tetrahydrocannabinol (THC).
Heavy smoker or user of other types of nicotine products (greater than [>] 20 cigarettes equivalent per day).
Unable to abstain from smoking for at least 2 hours before and at least 8 hours after dosing.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Altasciences
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 5-Way Crossover Study Evaluating the Abuse Potential of Soticlestat (TAK-935) in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System Depressant Experience

The main aim is to evaluate the relative abuse potential of soticlestat in healthy adults who has used central nervous system (CNS) depressants for recreational nontherapeutic reasons.

Read the detailed description

The drug being tested in this study is called soticlestat. Soticlestat is being tested in healthy participants. This study will assess the relative abuse potential of soticlestat compared to alprazolam and placebo in healthy adult, nondependent recreational drug users with CNS depressant experience. The study will enroll approximately 110 participants. Participants will be randomly (by chance, like flipping a coin) assigned to treatments of the study.

Treatment order will remain undisclosed to the participants and study doctor (unless there is an urgent medical need). This single center trial will be conducted in the United States. Participants will be followed up for up to 7 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 11 weeks.

Conditions: Healthy Volunteers
Being tested: Soticlestat 300 mg, Soticlestat 600 mg, Soticlestat 900 mg, Alprazolam, Placebo
Keywords: Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Soticlestat 300 mgDrug
Administered orally.
Soticlestat 600 mgDrug
Administered orally.
Soticlestat 900 mgDrug
Administered orally.
AlprazolamDrug
Administered orally.
PlaceboDrug
Administered orally.

Study groups in NCT05602818
Study group	Role	What they receive
Soticlestat 300 mg	Experimental	Participants will receive a single oral dose of soticlestat 300 milligrams (mg). Receives: Drug: Soticlestat 300 mg
Soticlestat 600 mg	Experimental	Participants will receive a single oral dose of soticlestat 600 mg. Receives: Drug: Soticlestat 600 mg
Soticlestat 900 mg	Experimental	Participants will receive a single oral dose of soticlestat 900 mg. Receives: Drug: Soticlestat 900 mg
Alprazolam 2 mg	Active comparator	Participants will receive a single oral dose of over encapsulated alprazolam 2 mg. Receives: Drug: Alprazolam
Placebo	Placebo comparator	Participants will receive a single oral dose of matching placebo. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS)
Drug liking ("at this moment") assessed how much a participant likes or dislikes a drug effect at the time the question was being asked. It was scored using a 0 to 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates stronger liking.
Measured: Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose

Secondary outcomes (6)

Treatment Phase: Overall Drug Liking (Emax) Assessed Using Bipolar VAS
Overall drug liking assesses participant's overall experience with the drug by assessing the participant's overall liking for the drug. It was scored using a 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates better liking. The "overall drug liking" was an independent measure and not an "at this moment" assessment.
Measured: Day 1 of each Treatment Period: 12 and 24 hours post-dose
Treatment Phase: Take Drug Again (Emax) Assessed "Overall" by Using Bipolar VAS
Take drug again was a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It was scored using a 0 to 100-point bipolar VAS, where 0: Definitely not, 50: Neutral, 100: Definitely so. A higher score indicates stronger desire.
Measured: Day 1 of each Treatment Period: 12 and 24 hours post-dose
Treatment Phase: Bad Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS
Bad drug effects assessed the bad effect of drug experienced by the participant at the time the question is being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger bad drug effect.
Measured: Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose
Treatment Phase: Good Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS
Good drug effects assessed the good effect of drug experienced by the participant at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and range from 0 (Not at all) to 100 (extremely). A higher score indicated a stronger good drug effect.
Measured: Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose
Treatment Phase: High (Emax) Assessed "At This Moment" by Using Unipolar VAS
High assessed the degree that a participant feels a good effect (that is, euphoria) at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger high effect.
Measured: Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose
Treatment Phase: Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event that started or worsened during or after the first dose of study drug.
Measured: From start of study drug administration (Day 1) up to Day 37

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 20227 Jul 2023

First posted2 Nov 2022
Study start15 Nov 2022
Primary completion29 Jun 2023
Study completion7 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05602818
Sponsor's protocol ID: TAK-935-1012
Status last verified: Aug 2026
First submitted: 28 Oct 2022
Last updated: 16 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 5-Way Crossover Study Evaluating the Abuse Potential of Soticlestat (TAK-935) in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System Depressant Experience
ClinicalTrials.gov ID: NCT05602818
Acronym / sponsor ID: TAK-935-1012
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 15 Nov 2022 (actual)
Primary completion: 29 Jun 2023 (actual)
Study completion: 7 Jul 2023 (actual)
First posted: 2 Nov 2022 (actual)
Results: Posted 9 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main aim is to evaluate the relative abuse potential of soticlestat in healthy adults who has used central nervous system (CNS) depressants for recreational nontherapeutic reasons.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Soticlestat 300 mg	Experimental	Drug: Soticlestat 300 mgParticipants will receive a single oral dose of soticlestat 300 milligrams (mg).
Soticlestat 600 mg	Experimental	Drug: Soticlestat 600 mgParticipants will receive a single oral dose of soticlestat 600 mg.
Soticlestat 900 mg	Experimental	Drug: Soticlestat 900 mgParticipants will receive a single oral dose of soticlestat 900 mg.
Alprazolam 2 mg	Active comparator	Drug: AlprazolamParticipants will receive a single oral dose of over encapsulated alprazolam 2 mg.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive a single oral dose of matching placebo.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy as determined by the investigator.
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.
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.

Key exclusion criteria (5 listed)

Self-reported history of drug or alcohol dependence (within the past 1 year, except caffeine or nicotine, prior to the screening visit).
Positive alcohol breathalyzer or urine drug screen (UDS) for substances of abuse at admission, excluding tetrahydrocannabinol (THC).
Heavy smoker or user of other types of nicotine products (greater than [>] 20 cigarettes equivalent per day).
Unable to abstain from smoking for at least 2 hours before and at least 8 hours after dosing.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Soticlestat 300 mgAdministered orally.	Drug	Soticlestat 300 mg
Soticlestat 600 mgAdministered orally.	Drug	Soticlestat 600 mg
Soticlestat 900 mgAdministered orally.	Drug	Soticlestat 900 mg
AlprazolamAdministered orally.	Drug	Alprazolam 2 mg
PlaceboAdministered orally.	Drug	Placebo

Primary outcome

Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS)
Time frame: Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose
Drug liking ("at this moment") assessed how much a participant likes or dislikes a drug effect at the time the question was being asked. It was scored using a 0 to 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates stronger liking.

6 secondary outcomes

Treatment Phase: Overall Drug Liking (Emax) Assessed Using Bipolar VAS
Time frame: Day 1 of each Treatment Period: 12 and 24 hours post-dose
Treatment Phase: Take Drug Again (Emax) Assessed "Overall" by Using Bipolar VAS
Time frame: Day 1 of each Treatment Period: 12 and 24 hours post-dose
Treatment Phase: Bad Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS
Time frame: Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose
Treatment Phase: Good Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS
Time frame: Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose
Treatment Phase: High (Emax) Assessed "At This Moment" by Using Unipolar VAS
Time frame: Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose
Treatment Phase: Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: From start of study drug administration (Day 1) up to Day 37

Results and safety

Results posted to the registry on 9 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Qualification Phase: Sequence 1	50	33
Qualification Phase: Sequence 2	50	36
Treatment Phase, Sequence 1: ABECD	0	0
Treatment Phase, Sequence 2: BCADE	0	0
Treatment Phase, Sequence 3: CDBEA	0	0
Treatment Phase, Sequence 4: DECAB	0	0
Treatment Phase, Sequence 5: EADBC	0	0
Treatment Phase, Sequence 6: DCEBA	0	0
Treatment Phase, Sequence 7: EDACB	0	0
Treatment Phase, Sequence 8: AEBDC	0	0
Treatment Phase, Sequence 9: BACED	0	0
Treatment Phase, Sequence 10: CBDAE	0	0

Primary outcome: Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS)

Time frame: Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose. Mean (Standard Error). Unit: score on a scale

Measure	Treatment Phase: Soticlestat 300 mg n = 48	Treatment Phase: Soticlestat 600 mg n = 48	Treatment Phase: Soticlestat 900 mg n = 48	Treatment Phase: Alprazolam 2 mg n = 48	Treatment Phase: Placebo n = 48
Value	56.7 (1.87)	57.3 (1.89)	56.5 (1.55)	88.5 (1.58)	55.6 (1.63)

Population analysed: The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: TEAEs are AEs that started after the first dose of study drug administration (Day 1) up to Day 3 for Qualification Phase and up to Day 37 for Treatment Phase. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Qualification Phase: Placebo	0 of 96 (0%)	2 of 96 (2.1%)	0 of 96
Qualification Phase: Alprazolam 2 mg	0 of 98 (0%)	83 of 98 (84.7%)	0 of 98
Treatment Phase: Soticlestat 300 mg	0 of 63 (0%)	14 of 63 (22.2%)	0 of 63
Treatment Phase: Soticlestat 600 mg	0 of 63 (0%)	10 of 63 (15.9%)	0 of 63
Treatment Phase: Soticlestat 900 mg	0 of 61 (0%)	9 of 61 (14.8%)	0 of 61
Treatment Phase: Alprazolam 2 mg	0 of 59 (0%)	50 of 59 (84.7%)	0 of 59
Treatment Phase: Placebo	0 of 62 (0%)	8 of 62 (12.9%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this link.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Soticlestat 300 mg, Soticlestat 600 mg and Soticlestat 900 mg in people with Healthy Volunteers, run by Takeda at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS) (time frame: Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05602818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.