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Hepatic ImpairmentPhase 1NCT05098054

A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function

A Phase 1 study testing Soticlestat in people with Hepatic Impairment and Healthy Volunteers, run by Takeda at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main aim is to check the effect of a single dose of soticlestat in adults with moderate or mild liver failure compared to healthy adults with normal liver function. Participants will check into the study clinic for 8 days. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment, Healthy Volunteers
What is being tested?
Soticlestat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
6 sitesin 2 countries
Study dates
29 Oct 2021to 7 Jun 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Inclusion Criteria A. For Participants with Hepatic Impairment

  1. Has a BMI greater than or equal to (>=) 18.0 and less than or equal to (<=) 40.0 kilogram per square meter (kg/m^2), at screening. At least 50% of the participants will be required to be of BMI >=18.0 and <=35.0 kg/m^2, at screening.
  • Supine blood pressure (BP) is >=80/40 millimeter of mercury (mmHg) (asymptomatic) and <=150/95 mmHg at screening;
  • Supine pulse rate (PR) is >=40 beats per minute (bpm) and <=99 bpm, at screening;
  • QT interval corrected for heart rate using Fridericia's formula (QTcF) is <=500 millisecond (msec) and ECG findings considered normal or not clinically significant by the Investigator or designee, at screening.
  1. Must have had chronic HI for at least 3 months before screening, and the HI must be stable, that is, no significant changes in hepatic function in the 30 days preceding screening (or since the last visit if within 6 months before screening) and treatment with stable doses of medication. Has a score on the Child-Pugh Class at screening as follows:
  • (Arm 1) Moderate HI, Child-Pugh Class B: >=7 and <=9
  • (Arm 2) Mild HI, Child-Pugh Class A: >=5 and <=6
  1. Should not have renal dysfunction as demonstrated by a relatively adequate renal function (creatinine clearance >=50 milliliter per minute [mL/min]), at screening.
  2. For Healthy Participants
  3. Has a BMI >=18.0 and <=40.0 kg/m^2, at screening. At least 50% of the participants will be required to be of BMI >=18.0 and <=35.0 kg/m^2, at screening. Healthy participants will be matched to hepatic impaired participants in this study by age (mean ±10 years), sex (±2 per sex), and BMI, mean ±10%.
  • Supine BP is >=90/40 mmHg and <=150/95 mmHg, at screening;
  • Supine PR is >=40 bpm and <=99 bpm, at screening;
  • QTcF is <=450 msec (males) or <=470 msec (females) and ECG findings considered normal or not clinically significant by the Investigator or designee, at screening;
  • Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and total bilirubin <= the upper limit of normal (ULN) at screening and check-in.
  1. Should not have renal dysfunction as demonstrated by a relatively adequate renal function (creatinine clearance >=60 mL/min), at screening.
  2. For Participants with Hepatic Impairment and Healthy Participants
  3. Continuous non-smoker or moderate smoker (<=10 cigarettes/day or the equivalent) before screening. Participant must agree to consume no more than 5 cigarettes or equivalent/day from the 7 days prior check-in and until discharge from the Clinical Research Unit (CRU).

Exclusion Criteria A. For Participants with Hepatic Impairment

  1. Has history or presence of clinically significant medical or psychiatric condition or disease (aside from HI) or presence of psychotic disorders such as psychosis, delusions, or schizophrenia in the opinion of the Investigator or designee.
  2. Has a history of liver or other solid organ transplant.
  3. Positive result at screening for human immunodeficiency virus (HIV). Hepatitis B surface antigen (HBsAg) positive participants are allowed to be enrolled if Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is below 1000 copies per milliliter (/mL) in the plasma. Participants with moderate or mild HI who are positive for Hepatitis C virus antibodies (HCVAb) can be enrolled but must not have detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) in the plasma.
  4. For Healthy Participants
  5. Has history or presence of clinically significant medical or psychiatric condition or disease or presence of psychotic disorders such as psychosis, delusions, or schizophrenia in the opinion of the Investigator or designee.
  6. Positive results at screening for HIV, HBsAg, or HCV.
  7. For Participants with Hepatic Impairment and Healthy Participants
  8. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to dosing.
  9. Any positive responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) or has a risk of suicide according to the Investigator's judgment based on the assessment of the C-SSRS at screening or check-in or has made a suicide attempt in the previous 12 months prior to dosing.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States5 sites
  • Velocity

    Edgewater, Florida, 32132

  • Clinical Pharmacology of Miami

    Miami, Florida, 33014

  • Orlando Clinical Research Center

    Orlando, Florida, 32809-3017

  • Texas Liver Institute

    San Antonio, Texas, 78215

  • GCP

    St. Petersburg, Florida, 33705

Other trials in United States

Hungary1 site
  • CRU Hungary Unit Pest Country Flor Ferenc Hospital

    Kistarcsa, 2143

Other trials in Hungary

About this study

Official title: Phase 1 Pharmacokinetics and Safety Study of Oral Soticlestat in Participants With Moderate or Mild Hepatic Impairment and Normal Hepatic Function

The main aim is to check the effect of a single dose of soticlestat in adults with moderate or mild liver failure compared to healthy adults with normal liver function.

Participants will check into the study clinic for 8 days. During the stay, one oral dose of soticlestat will be given and the participant will be monitored. The clinic staff will follow up with the participant about a week after discharge from the clinic.

Read the detailed description

The drug being tested in this study is called soticlestat (TAK-935). The study will assess the safety and tolerability of single oral dose of soticlestat in participants with moderate or mild Hepatic Impairment (HI) compared to healthy participants matched by age (mean ±10 years), sex (±2 per sex), and body mass index (BMI, mean ±10 percent [%]) with normal hepatic function.

The study will enroll approximately 40 participants. Participants will be assigned to following study arms:

  • Arm 1, Moderate HI: Soticlestat 300 milligram (mg) (Child-Pugh Class B)
  • Arm 2, Mild HI: Soticlestat 300 mg (Child-Pugh Class A)
  • Arm 3, Normal hepatic function: Soticlestat 300 mg

All participants will receive single oral dose of study drug. The data will be collected and stored in electronic case report form (eCRF).

This multi-center trial will be conducted in the United States and Hungary. The overall duration of the study is approximately 42 days. Participants will be followed up for 14 days after the last dose of study drug for a follow-up assessment.

Being tested
Soticlestat
Keywords
Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SoticlestatDrug

    Also called TAK-935

    Soticlestat tablets.

Study groups in NCT05098054
Study groupRoleWhat they receive
Arm 1, Moderate HI: Soticlestat 300 mgExperimentalSoticlestat 300 mg, tablets, orally, once on Day 1 to participant with moderate HI.
Receives: Drug: Soticlestat
Arm 2, Mild HI: Soticlestat 300 mgExperimentalSoticlestat 300 mg, tablets, orally, once on Day 1 to participant with mild HI.
Receives: Drug: Soticlestat
Arm 3, Normal hepatic function: Soticlestat 300 mgExperimentalSoticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants.
Receives: Drug: Soticlestat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax: Maximum Observed Plasma Concentration for Soticlestat

    Measured: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose

  2. AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for Soticlestat

    Measured: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose

  3. AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Soticlestat

    Measured: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose

Secondary outcomes (1)
  1. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

    An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened at the time of or after dosing of study drug.

    Measured: From Day 1 up to 16 days after the last dose of study drug (up to Day 17)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2021
  2. Study start29 Oct 2021
  3. Primary completion31 May 2022
  4. Study completion7 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05098054
Sponsor's protocol ID
TAK-935-1010
Other IDs
2021-006373-29
Status last verified
Aug 2026
First submitted
20 Oct 2021
Last updated
15 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Soticlestat in people with Hepatic Impairment and Healthy Volunteers, run by Takeda at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax: Maximum Observed Plasma Concentration for Soticlestat (time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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