At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Soticlestatdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1 Pharmacokinetics and Safety Study of Oral Soticlestat in Participants With Moderate or Mild Hepatic Impairment and Normal Hepatic Function
In Brief
A Phase 1 clinical trial evaluating Soticlestat for Hepatic Impairment and Healthy Volunteers. Completed, enrolled 36 participants across 6 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment, Healthy Volunteers
CountriesHungary, United States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartOct 2021
Primary CompletionMay 2022
Study CompletionJun 2022
TodayJul 2026
First PostedOct 28, 2021
Enrollment StartOct 29, 2021
Primary CompletionMay 31, 2022
Study CompletionJun 7, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.7 years ago
Interventions
Soticlestatdrug
Soticlestat tablets.