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COMPLETED
NCT05098054
PHASE1

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

Sponsor: Takeda

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2021-10-29

Completion Date

2022-06-07

Last Updated

2026-09-15

Healthy Volunteers

Yes

Interventions

DRUG

Soticlestat

Soticlestat tablets.

Locations (6)

Velocity

Edgewater, Florida, United States

Clinical Pharmacology of Miami

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

GCP

St. Petersburg, Florida, United States

Texas Liver Institute

San Antonio, Texas, United States

CRU Hungary Unit Pest Country Flor Ferenc Hospital

Kistarcsa, Hungary