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A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function
NCT05098054 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Soticlestat
Study Locations (6)
Florida
- Velocity — Edgewater
- Clinical Pharmacology of Miami — Miami
- Orlando Clinical Research Center — Orlando
- GCP — St. Petersburg
Texas
- Texas Liver Institute — San Antonio
Other
- CRU Hungary Unit Pest Country Flor Ferenc Hospital — Kistarcsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2021-10-29 |
| Est. Completion | 2022-06-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05098054
The ClinicalTrials.gov registry entry for NCT05098054 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention — of which Soticlestat is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05098054 reports 6 study locations spanning 3 distinct geographic areas — top geographies include Florida, Texas, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05098054 about?
NCT05098054 is a clinical study titled "A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function". 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 part...
What is the current status of trial NCT05098054?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2021-10-29. Estimated completion is 2022-06-07.
What conditions does trial NCT05098054 study?
This clinical trial studies the following conditions: Healthy Volunteers, Hepatic Impairment. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05098054?
The interventions under investigation include: Soticlestat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05098054?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05098054 being conducted?
This trial has 6 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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