Phase 1
N=36
A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function
Hepatic Impairment · Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05098054 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Cmax: Maximum Observed Plasma Concentration for Soticlestat — 3230; 3666; 1435; 1705 nanogram per milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Soticlestat (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Soticlestat |
3230; 3666; 1435; 1705; 986.9 | — |
| PRIMARY AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for Soticlestat |
2980; 5760; 1539; 1925; 1182 | — |
| PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Soticlestat |
2960; 5732; 1522; 1812; 1126 | — |
| SECONDARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) |
1; 1; 1; 2 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria A. For Participants with Hepatic Impairment
- Has a BMI greater than or equal to (>=) 18.0 and less than or equal to ( =18.0 and =80/40 millimeter of mercury (mmHg) (asymptomatic) and =40 beats per minute (bpm) and =7 and =5 and =50 milliliter per minute [mL/min]), at screening.
B. For Healthy Participants
- Has a BMI >=18.0 and =18.0 and =90/40 mmHg and =40 bpm and =60 mL/min), at screening.
C. For Participants with Hepatic Impairment and Healthy Participants
- 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
- 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.
- Has a history of liver or other solid organ transplant.
- 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
- 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.
- Positive results at screening for HIV, HBsAg, or HCV.
C. For Participants with Hepatic Impairment and Healthy Participants
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT05098054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.