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Part B, Sequence 4: Treatment E + Treatment F + Treatment D for Healthy Subjects

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

Study Summary

The main aim is to see how soticlestat tablets of different strengths work and to compare how it works alone in contrast to administration along with food. In the study will be 2 groups of participants (part A and part B). Participants in part A will receive 300 mg of soticlestat administered in different kind of tablets (regular tablets, mini-tablets, commercial tablets) and participant in part B will also receive 300 mg of soticlestat in tablets but with food and crushed tablets with applesauce. Participants will complete several assessments including clinical laboratory evaluations, physical examinations, Columbia-Suicide Severity Rating Scale (C-SSRS) assessment, electrocardiographs (ECGs), and vital signs.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat
Cmax: Maximum Observed Plasma Concentration for Soticlestat
Secondary outcome measures
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

Side effects data

From 2020 Phase 2 trial • 20 Patients • NCT03694275
25%
Seizure
25%
Fatigue
25%
Lethargy
13%
Agitation
13%
Apnoea
13%
Anaphylactic reaction
13%
Eosinophilia
13%
Hypotonia
13%
Diarrhoea
13%
Hypersomnia
13%
Sinusitis
13%
Upper respiratory tract infection
13%
Face injury
13%
Fall
13%
Activated partial thromboplastin time prolonged
13%
Anticonvulsant drug level increased
13%
International normalised ratio increased
13%
Balance disorder
13%
Drooling
13%
Rash
13%
Pruritus
13%
Pain
13%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Soticlestat Dup15q
Soticlestat CDD

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
~490

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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
1,203 Previous Clinical Trials
4,177,940 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
489,413 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Soticlestat Tablets in Healthy Adults
2022. "A Study of Soticlestat Tablets in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05284760.
~31 spots leftby Apr 2025
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