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NCT05064449 · ClinicalTrials.gov registry record · Phase 1
A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT05064449: Completed Phase 1 study, sponsored by Takeda.
NCT05064449 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05064449, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The main aim of this study is to check how itraconazole and mefenamic acid affect the way soticlestat is processed by the body. The study will have 2 parts. Participants can only participate in one study part. Part 1: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving itraconazole and will stay in the clinic for 11 more days, receiving soticlestat in combination with itraconazole on one of those days. Participants will be contacted about 8 days after leaving the clinic for follow-up. Part 2: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving mefenamic acid and will stay in the clinic for 7 more days, receiving soticlestat in combination with mefenamic acid on one of those days.. Participants will be contacted about 9 days after leaving the clinic for follow-up.
Interventions
- DRUG Itraconazole
- DRUG Soticlestat
- DRUG Mefenamic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2021-11-30 |
| Phase | Phase 1 |
What the finished NCT05064449 record still lists
NCT05064449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Itraconazole is the first listed.
NCT05064449 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05064449 about?
NCT05064449 is a clinical study titled "A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults". The main aim of this study is to check how itraconazole and mefenamic acid affect the way soticlestat is processed by the body. The study will have 2 parts. Participants can only participate in one study part. Part 1: Participants will check into the study clinic to receive soticlestat, four days ...
What is the current status of trial NCT05064449?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-10-14. Estimated completion is 2021-11-30.
What interventions are being tested in trial NCT05064449?
The interventions under investigation include: Itraconazole (DRUG), Soticlestat (DRUG), Mefenamic acid (DRUG).
Who is sponsoring clinical trial NCT05064449?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05064449's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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