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NCT03887884 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)
A Phase 1 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT03887884: Completed Phase 1 study, sponsored by Acorda Therapeutics.
NCT03887884 is a Phase 1 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03887884, a Phase 1 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This study will be an open-label, randomized, multi-center, 2-way crossover Pharmacokinetic PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease (PD) patients who regularly take CD/LD.
Primary Outcome
Maximum observed plasma drug concentration (Cmax) of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson's disease (PD) in a fed state.
Interventions
- DRUG CVT-301
- DRUG Sinemet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2019-03-05 |
| Est. Completion | 2019-06-28 |
| Phase | Phase 1 |
What the finished NCT03887884 record still lists
NCT03887884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which CVT-301 is the first listed.
NCT03887884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03887884 about?
NCT03887884 is a clinical study titled "Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)". This study will be an open-label, randomized, multi-center, 2-way crossover Pharmacokinetic PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease (PD) patients who regularly take ...
What is the current status of trial NCT03887884?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2019-03-05. Estimated completion is 2019-06-28.
What interventions are being tested in trial NCT03887884?
The interventions under investigation include: CVT-301 (DRUG), Sinemet (DRUG).
Who is sponsoring clinical trial NCT03887884?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03887884's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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