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NCT04676685 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety and Tolerability of E2730 After Multiple Dose and the Food Effect After Single Dose in Healthy Participants
A Phase 1 study of Healthy Volunteers, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT04676685: Completed Phase 1 study of Healthy Volunteers, sponsored by Eisai.
NCT04676685 is a Phase 1 study of Healthy Volunteers that has completed, run by Eisai. The registered enrollment target is 32 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04676685, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E2730 of multiple ascending oral doses in healthy adult participants and to assess the differences in PK, safety, and tolerability of E2730 between healthy Japanese and non-Japanese participants following multiple doses. This study will also determine the effect of food on PK of E2730.
Primary Outcome
Safety assessments will consist of monitoring and recording all adverse events (AEs); laboratory evaluation for hematology, clinical chemistry, and urinalysis; periodic measurement of vital signs, electrocardiograms (ECGs), electroencephalogram (EEGs), corrected QT (QTc) interval and blood pressure.
Conditions Studied
Interventions
- DRUG E2730
- DRUG E2730-matched placebo
Study Locations (1)
California
- Collaborative Neuroscience Research, LLC. - Long Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-12-16 |
| Est. Completion | 2021-06-23 |
| Phase | Phase 1 |
What the finished NCT04676685 record still lists
NCT04676685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 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 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which E2730 is the first listed.
NCT04676685 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04676685 about?
NCT04676685 is a clinical study titled "A Study to Assess the Safety and Tolerability of E2730 After Multiple Dose and the Food Effect After Single Dose in Healthy Participants". The primary purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E2730 of multiple ascending oral doses in healthy adult participants and to assess the differences in PK, safety, and tolerability of E2730 between healthy Japanese and non-Japanese participants fo...
What is the current status of trial NCT04676685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2020-12-16. Estimated completion is 2021-06-23.
What conditions does trial NCT04676685 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04676685?
The interventions under investigation include: E2730 (DRUG), E2730-matched placebo (DRUG).
Who is sponsoring clinical trial NCT04676685?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04676685 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04676685's enrollment target sits among peer trials
32 171st of 283 higher than 99 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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