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NCT05284760 · ClinicalTrials.gov registry record · Phase 1
A Study of Soticlestat Tablets in Healthy Adults
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
NCT05284760 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 96 participants.
The verdict
NCT05284760, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
Study Summary
The main aim is to see how soticlestat tablets of different strengths work and to compare how it works alone in contrast to administration along with food. In the study will be 2 groups of participants (part A and part B). Participants in part A will receive 300 mg of soticlestat administered in different kind of tablets (regular tablets, mini-tablets, commercial tablets) and participant in part B will also receive 300 mg of soticlestat in tablets but with food and crushed tablets with applesauce. Participants will complete several assessments including clinical laboratory evaluations, physical examinations, Columbia-Suicide Severity Rating Scale (C-SSRS) assessment, electrocardiographs (ECGs), and vital signs.
Interventions
- DRUG Soticlestat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2022-06-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05284760
The ClinicalTrials.gov registry entry for NCT05284760 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Soticlestat is the first listed.
NCT05284760 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05284760 about?
NCT05284760 is a clinical study titled "A Study of Soticlestat Tablets in Healthy Adults". The main aim is to see how soticlestat tablets of different strengths work and to compare how it works alone in contrast to administration along with food. In the study will be 2 groups of participants (part A and part B). Participants in part A will receive 300 mg of soticlestat administered in di...
What is the current status of trial NCT05284760?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2022-03-11. Estimated completion is 2022-06-02.
What interventions are being tested in trial NCT05284760?
The interventions under investigation include: Soticlestat (DRUG).
Who is sponsoring clinical trial NCT05284760?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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