Phase 1
N=100
A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05602818 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS) — 56.7; 57.3; 56.5; 88.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Soticlestat 300 mg (Drug); Soticlestat 600 mg (Drug); Soticlestat 900 mg (Drug); Alprazolam (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS) |
56.7; 57.3; 56.5; 88.5; 55.6 | — |
| SECONDARY Treatment Phase: Overall Drug Liking (Emax) Assessed Using Bipolar VAS |
58.2; 58.5; 59.5; 90.0; 58.0 | — |
| SECONDARY Treatment Phase: Take Drug Again (Emax) Assessed "Overall" by Using Bipolar VAS |
58.5; 57.6; 58.4; 92.0; 57.1 | — |
| SECONDARY Treatment Phase: Bad Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS |
2.3; 1.4; 2.5; 28.5; 1.2 | — |
| SECONDARY Treatment Phase: Good Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS |
10.9; 10.1; 11.6; 74.0; 8.1 | — |
| SECONDARY Treatment Phase: High (Emax) Assessed "At This Moment" by Using Unipolar VAS |
10.3; 12.0; 11.3; 72.8; 8.1 | — |
| SECONDARY Treatment Phase: Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) |
17; 12; 13; 52; 15 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05602818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.