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

NCT05602818 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-09

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Soticlestat 300 mg

Administered orally.

DRUG

Soticlestat 600 mg

Administered orally.

DRUG

Soticlestat 900 mg

Administered orally.

DRUG

Alprazolam

Administered orally.

DRUG

Placebo

Administered orally.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2023-06-29
Completion
2023-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05602818 on ClinicalTrials.gov