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

NCT05098054 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TAK-935-10102021-006373-29
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 6

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.

Conditions

Hepatic Impairment; Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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)

Study Arms (3)

Arm 1, Moderate HI: Soticlestat 300 mg

EXPERIMENTAL

Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with moderate HI.

Drug: Soticlestat

Arm 2, Mild HI: Soticlestat 300 mg

EXPERIMENTAL

Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with mild HI.

Drug: Soticlestat

Arm 3, Normal hepatic function: Soticlestat 300 mg

EXPERIMENTAL

Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants.

Drug: Soticlestat

Interventions

Soticlestat DRUG

Soticlestat tablets.

Also known as: TAK-935

Arm 1, Moderate HI: Soticlestat 300 mg; Arm 2, Mild HI: Soticlestat 300 mg; Arm 3, Normal hepatic function: Soticlestat 300 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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
• 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.
• Should not have renal dysfunction as demonstrated by a relatively adequate renal function (creatinine clearance \>=60 mL/min), at screening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (6)

Velocity

Edgewater, Florida, 32132, United States

Location

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809-3017, United States

Location

GCP

St. Petersburg, Florida, 33705, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

CRU Hungary Unit Pest Country Flor Ferenc Hospital

Kistarcsa, 2143, Hungary

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Interventions

soticlestat

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 28, 2021
• Study Start: October 29, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 7, 2022
• Last Updated: February 2, 2024
• Results First Posted: February 2, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

HU (1); US (5)