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

Phase 1

Completed

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm 2, Mild HI: Soticlestat 300 mg	Soticlestat	Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with mild HI.
Arm 1, Moderate HI: Soticlestat 300 mg	Soticlestat	Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with moderate HI.
Arm 3, Normal hepatic function: Soticlestat 300 mg	Soticlestat	Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants.

Primary Outcome Measures

Name	Time	Method
Cmax: Maximum Observed Plasma Concentration for Soticlestat	Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for Soticlestat	Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Soticlestat	Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)	From Day 1 up to 16 days after the last dose of study drug (up to Day 17)	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.

Locations (6): Velocity
🇺🇸
Edgewater, Florida, United States
GCP
🇺🇸
Saint Petersburg, Florida, United States
CRU Hungary Unit Pest Country Flor Ferenc Hospital
🇭🇺
Kistarcsa, Hungary
Clinical Pharmacology of Miami
🇺🇸
Miami, Florida, United States
Orlando Clinical Research Center
🇺🇸
Orlando, Florida, United States
Texas Liver Institute
🇺🇸
San Antonio, Texas, United States