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Small Molecule

Soticlestat 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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 up to 16 days after the last dose of study drug (up to day 17)
Awards & highlights

Study Summary

This study is evaluating whether a drug called soticlestat can improve liver function in people with liver failure.

Eligible Conditions
  • Healthy Subjects
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to 16 days after the last dose of study drug (up to day 17)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to 16 days after the last dose of study drug (up to day 17) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for Soticlestat
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration 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

3Treatment groups
Experimental Treatment
Group I: Arm 3, Normal hepatic function: Soticlestat 300 mgExperimental Treatment1 Intervention
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants.
Group II: Arm 2, Mild HI: Soticlestat 300 mgExperimental Treatment1 Intervention
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with mild HI.
Group III: Arm 1, Moderate HI: Soticlestat 300 mgExperimental Treatment1 Intervention
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with moderate HI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soticlestat
2022
Completed Phase 3
~490

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TakedaLead Sponsor
1,201 Previous Clinical Trials
4,178,098 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,206 Previous Clinical Trials
489,618 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 in Adults With Liver Failure Compared to Those With Normal Liver Function
2021. "A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05098054.
~11 spots leftby Apr 2025
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