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NCT05098054 · ClinicalTrials.gov registry record · Phase 1
A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function
A Phase 1 study of Healthy Volunteers and Hepatic Impairment, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 6
- Study locations
NCT05098054: Completed Phase 1 study of Healthy Volunteers and Hepatic Impairment, sponsored by Takeda.
NCT05098054 is a Phase 1 study of Healthy Volunteers and Hepatic Impairment that has completed, run by Takeda. The registered enrollment target is 36 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05098054, a Phase 1 study of Healthy Volunteers and Hepatic Impairment, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 6
- Study locations
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 |
What the finished NCT05098054 record still lists
NCT05098054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower).
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.
NCT05098054 lists 6 locations in 3 states (Florida, Texas, Other).
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.
What interventions are being tested in trial NCT05098054?
The interventions under investigation include: Soticlestat (DRUG).
Who is sponsoring clinical trial NCT05098054?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05098054's enrollment target sits among peer trials
36 166th of 283 higher than 115 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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