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A Study of Soticlestat Tablets in Healthy Adults

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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening up to 14 days after the last dose of soticlestat (day 51)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug called soticlestat in healthy participants to see how it is absorbed and processed by the body. The study will compare different tablet forms and the effects of taking the drug with or without food. Researchers will measure drug levels in the blood and monitor for any side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening up to 14 days after the last dose of soticlestat (day 51)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to 14 days after the last dose of soticlestat (day 51) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

Side effects data

From 2024 Phase 3 trial • 270 Patients • NCT04938427
14%
Somnolence
13%
Change in seizure presentation
8%
Upper respiratory tract infection
7%
Nasopharyngitis
7%
Pyrexia
6%
Decreased appetite
6%
COVID-19
6%
Fatigue
5%
Constipation
5%
Fall
1%
Diarrhoea
1%
Cataract
1%
Urinary tract infection
1%
Rhinovirus infection
1%
Status epilepticus
1%
Influenza
1%
Oxygen saturation decreased
1%
Pneumonia
1%
Vomiting
1%
Pyelonephritis
1%
COVID-19 pneumonia
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Soticlestat
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

12Treatment groups
Experimental Treatment
Group I: Part B, Sequence 5: Treatment F + Treatment D + Treatment EExperimental Treatment1 Intervention
Soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Group II: Part B, Sequence 4: Treatment E + Treatment F + Treatment DExperimental Treatment1 Intervention
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Group III: Part B, Sequence 3: Treatment F + Treatment E + Treatment DExperimental Treatment1 Intervention
Soticlestat T4 300 mg tablets, crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Group IV: Part B, Sequence 3: Treatment E + Treatment D + Treatment FExperimental Treatment1 Intervention
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Group V: Part B, Sequence 2: Treatment D + Treatment F + Treatment EExperimental Treatment1 Intervention
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Group VI: Part B, Sequence 1: Treatment D + Treatment E + Treatment FExperimental Treatment1 Intervention
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Group VII: Part A, Sequence 6: Treatment C + Treatment B + Treatment AExperimental Treatment1 Intervention
Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T3 mini-tablets 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Group VIII: Part A, Sequence 5: Treatment C + Treatment A + Treatment BExperimental Treatment1 Intervention
Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Group IX: Part A, Sequence 4: Treatment B + Treatment C + Treatment AExperimental Treatment1 Intervention
Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Group X: Part A, Sequence 3: Treatment B + Treatment A + Treatment CExperimental Treatment1 Intervention
Soticlestat T3 mini-tablets 300 milligram (mg), orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Group XI: Part A, Sequence 2: Treatment A + Treatment C + Treatment BExperimental Treatment1 Intervention
Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Group XII: Part A, Sequence 1: Treatment A + Treatment B + Treatment CExperimental Treatment1 Intervention
Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days will be maintained between each Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soticlestat
2022
Completed Phase 3
~640

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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
1,240 Previous Clinical Trials
4,149,375 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,290 Previous Clinical Trials
502,416 Total Patients Enrolled
~26 spots leftby Dec 2025
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