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NCT04384666 · ClinicalTrials.gov registry record · Phase 1
A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers
A Phase 1 study, sponsored by Luye Pharma Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT04384666: Completed Phase 1 study, sponsored by Luye Pharma Group.
NCT04384666 is a Phase 1 study that has completed, run by Luye Pharma Group. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04384666, a Phase 1 study, has completed, sponsored by Luye Pharma Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is a randomized, open-label, 2-sequence, 2-treatment cross-over study in healthy adult subjects. Rotigotine PK profiles will be obtained from all subjects after both a single dose of 28 mg LY03003 and 1 week of 4 mg q24h NEUPRO® patch. Subjects will be randomized 1:1 to 1 of the 2 treatment sequences.
Interventions
- DRUG LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection)
- OTHER Neupro 4 mg / 24 Hr. Transdermal Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2020-06-02 |
| Est. Completion | 2020-08-10 |
| Phase | Phase 1 |
What the finished NCT04384666 record still lists
NCT04384666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection) is the first listed.
NCT04384666 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04384666 about?
NCT04384666 is a clinical study titled "A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers". This is a randomized, open-label, 2-sequence, 2-treatment cross-over study in healthy adult subjects. Rotigotine PK profiles will be obtained from all subjects after both a single dose of 28 mg LY03003 and 1 week of 4 mg q24h NEUPRO® patch. Subjects will be randomized 1:1 to 1 of the 2 treatment seq...
What is the current status of trial NCT04384666?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2020-06-02. Estimated completion is 2020-08-10.
What interventions are being tested in trial NCT04384666?
The interventions under investigation include: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection) (DRUG), Neupro 4 mg / 24 Hr. Transdermal Patch (OTHER).
Who is sponsoring clinical trial NCT04384666?
This trial is sponsored by Luye Pharma Group, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04384666's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 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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