Liver trouble changes how drugs work: scientists test soticlestat
NCT ID NCT05098054
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are studying how a single oral dose of soticlestat behaves in adults with mild or moderate liver impairment compared with healthy adults. The trial measures drug levels in the blood and tracks side effects over an 8-day clinic stay. The goal is to understand whether liver problems change how the body processes the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- soticlestat, an experimental oral drug also known as TAK-935
- What this could lead to
- If the drug behaves predictably in people with liver impairment, it could inform future dosing guidance for those patients.
- What could go wrong
- This is a small, early-stage study in 36 people. It measures drug levels and safety over about a week, so it cannot show whether the drug works for any condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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36 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Jun 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 2. 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 3. Should not have renal dysfunction as demonstrated by a relatively adequate renal function (creatinine clearance \>=50 milliliter per minute \[mL/min\]), at screening. B. For Healthy Participants 1. 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. 2. Should not have renal dysfunction as demonstrated by a relatively adequate renal function (creatinine clearance \>=60 mL/min), at screening. C. For Participants with Hepatic Impairment and Healthy Participants 1\. 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. B. For Healthy Participants 1. 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. 2. Positive results at screening for HIV, HBsAg, or HCV. C. For Participants with Hepatic Impairment and Healthy Participants 1. 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. 2. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CRU Hungary Unit Pest Country Flor Ferenc Hospital
Kistarcsa, 2143, Hungary
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Clinical Pharmacology of Miami
Miami, Florida, 33014, United States
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GCP
St. Petersburg, Florida, 33705, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809-3017, United States
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Texas Liver Institute
San Antonio, Texas, 78215, United States
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Velocity
Edgewater, Florida, 32132, United States
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Other studies related to the condition(s) this trial covers.
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