NCT05602818

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2022

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 9, 2024

Completed
Last Updated

December 9, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 28, 2022

Results QC Date

June 28, 2024

Last Update Submit

October 24, 2024

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Day 1 of each Treatment Period: 12 and 24 hours post-dose

  • Treatment Phase: Take Drug Again (Emax) Assessed "Overall" by Using Bipolar VAS

    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

    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

    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

    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

  • +1 more secondary outcomes

Study Arms (5)

Soticlestat 300 mg

EXPERIMENTAL

Participants will receive a single oral dose of soticlestat 300 milligrams (mg).

Drug: Soticlestat 300 mg

Soticlestat 600 mg

EXPERIMENTAL

Participants will receive a single oral dose of soticlestat 600 mg.

Drug: Soticlestat 600 mg

Soticlestat 900 mg

EXPERIMENTAL

Participants will receive a single oral dose of soticlestat 900 mg.

Drug: Soticlestat 900 mg

Alprazolam 2 mg

ACTIVE COMPARATOR

Participants will receive a single oral dose of over encapsulated alprazolam 2 mg.

Drug: Alprazolam

Placebo

PLACEBO COMPARATOR

Participants will receive a single oral dose of matching placebo.

Drug: Placebo

Interventions

Soticlestat 300 mgDRUG

Administered orally.

Soticlestat 300 mg
Soticlestat 600 mgDRUG

Administered orally.

Soticlestat 600 mg
Soticlestat 900 mgDRUG

Administered orally.

Soticlestat 900 mg
AlprazolamDRUG

Administered orally.

Alprazolam 2 mg
PlaceboDRUG

Administered orally.

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altasciences

Overland Park, Kansas, 66212, United States

Location

Related Links

MeSH Terms

Interventions

soticlestatAlprazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Takeda
TrialDisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 2, 2022

Study Start

November 15, 2022

Primary Completion

June 29, 2023

Study Completion

July 7, 2023

Last Updated

December 9, 2024

Results First Posted

December 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
More information

Locations

US(1)