Soticlestat 900 mg for Healthy Subjects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy SubjectsSoticlestat 300 mg - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Day 1 up to 7 days after last dose of study drug (up to Day 40).

Day 40
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Hour 24
Bad Drug Effects (Emax) Assessed "at this moment" by Using Unipolar VAS
Pharmaceutical Preparations
Good Drug effects (Emax) Assessed "at this moment" by Using Unipolar VAS
High (Emax) Assessed "at this moment" by Using Unipolar VAS
Overall Drug Liking (Emax) Assessed Using Bipolar VAS.
Take Drug Again (Emax) Assessed "Overall" by Using Bipolar VAS

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Alprazolam 2 mg
1 of 5
Soticlestat 900 mg
1 of 5
Soticlestat 600 mg
1 of 5
Soticlestat 300 mg
1 of 5
Placebo
1 of 5

Active Control

Experimental Treatment

Non-Treatment Group

110 Total Participants · 5 Treatment Groups

Primary Treatment: Soticlestat 900 mg · Has Placebo Group · Phase 1

Soticlestat 900 mg
Drug
Experimental Group · 1 Intervention: Soticlestat 900 mg · Intervention Types: Drug
Soticlestat 600 mg
Drug
Experimental Group · 1 Intervention: Soticlestat 600 mg · Intervention Types: Drug
Soticlestat 300 mg
Drug
Experimental Group · 1 Intervention: Soticlestat 300 mg · Intervention Types: Drug
Alprazolam 2 mg
Drug
ActiveComparator Group · 1 Intervention: Alprazolam · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 up to 7 days after last dose of study drug (up to day 40).

Who is running the clinical trial?

TakedaLead Sponsor
1,119 Previous Clinical Trials
4,054,223 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,071 Previous Clinical Trials
475,492 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are healthy as determined by the investigator.