MedTrace Logo

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

NCT05098054 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-02-02

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Soticlestat

Soticlestat tablets.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-29
Primary Completion
2022-05-31
Completion
2022-06-07
FDA Drug
Yes

Countries

  • United States
  • Hungary

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05098054 on ClinicalTrials.gov