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Soticlestat 300 mg for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Healthy as determined by the investigator.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to 7 days after last dose of study drug (up to day 40).
Awards & highlights

Study Summary

This trial will test if a new drug has potential for abuse when used recreationally.

Eligible Conditions
  • Healthy Subjects

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have used certain drugs that can affect the central nervous system, such as benzodiazepines or barbiturates, for non-medical reasons at least 10 times in your life and at least once in the past 12 weeks. You have also used at least one other type of drug that can be abused, such as opioids or hallucinogens, at least 10 times in your life.
Select...
You are in good health according to the person running the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to 7 days after last dose of study drug (up to day 40).
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to 7 days after last dose of study drug (up to day 40). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmaceutical Preparations
Secondary outcome measures
Bad Drug Effects (Emax) Assessed "at this moment" by Using Unipolar VAS
Good Drug effects (Emax) Assessed "at this moment" by Using Unipolar VAS
High (Emax) Assessed "at this moment" by Using Unipolar VAS
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Soticlestat 900 mgExperimental Treatment1 Intervention
Participants will receive a single oral dose of soticlestat 900 mg.
Group II: Soticlestat 600 mgExperimental Treatment1 Intervention
Participants will receive a single oral dose of soticlestat 600 mg.
Group III: Soticlestat 300 mgExperimental Treatment1 Intervention
Participants will receive a single oral dose of soticlestat 300 milligrams (mg).
Group IV: Alprazolam 2 mgActive Control1 Intervention
Participants will receive a single oral dose of over encapsulated alprazolam 2 mg.
Group V: PlaceboPlacebo Group1 Intervention
Participants will receive a single oral dose of matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soticlestat 300 mg
2022
Completed Phase 1
~70
Soticlestat 600 mg
2022
Completed Phase 1
~70
Soticlestat 900 mg
2022
Completed Phase 1
~70

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TakedaLead Sponsor
1,198 Previous Clinical Trials
4,178,256 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,201 Previous Clinical Trials
489,510 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join the current trial as a volunteer?

"This medical trial is enlisting 110 individuals, aged 18 to 55 years old and with a BMI of 18.5-35kg/m^2, who have used CNS depressants recreationally at least 10 times in their lifetime, but specifically once within the 12 weeks before screening. In addition, patients must have recreational experience with another drug class associated with abuse (i.e., opioids, stimulants cannabinoids etc.) at least 10 times over their life span; they also need to be deemed healthy by investigators."

Answered by AI

How many individuals are actively participating in this investigation?

"Affirmative, the information present on clinicaltrials.gov suggests that this experiment is actively searching for volunteers to take part in it. It was publicly announced on November 15th 2022 and has since been updated for finalization purposes as of November 16th 2022. 110 participants will be recruited from a single medical facility."

Answered by AI

Has the FDA certified Soticlestat 300 mg for public use?

"Due to limited prior evidence of safety and efficacy, Soticlestat 300 mg was given a rating of 1 on the Power team's scale."

Answered by AI

Does this research study permit those above the age of sixty to participate?

"The age limit for this medical trial is 18 to 55 years old. There are 50 studies available for minors and 373 research programs targeting individuals over the age of 65."

Answered by AI

Are vacancies still available for the participants of this clinical trial?

"According to the information at clinicaltrials.gov, this medical research is actively looking for volunteers. This trial was first listed on November 15th 2022 and has seen a recent update taking place on November 16th 2022."

Answered by AI
~29 spots leftby Mar 2025