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NCT01961830 · ClinicalTrials.gov registry record · Phase 1
Intrapulmonary Pharmacokinetics of ME1100 in Healthy Volunteers
A Phase 1 study, sponsored by Meiji Seika Pharma Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT01961830: Completed Phase 1 study, sponsored by Meiji Seika Pharma Co..
NCT01961830 is a Phase 1 study that has completed, run by Meiji Seika Pharma Co.. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01961830, a Phase 1 study, has completed, sponsored by Meiji Seika Pharma Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is a single-center, open-label, single-dose study. The primary objective is to determine Epithelial Lining Fluid (ELF) levels of ME1100 after a single orally inhaled dose. The secondary objectives are to determine systemic exposure to inhaled ME1100 and to assess tolerability and safety of a single dose of ME1100 inhalation solution.
Primary Outcome
Each subject will undergo fiber-optic bronchoscopy for the collection of bronchoalveolar lavage fluid at one of the following time points:5 minutes after END of dosing, 0.5, 1, 3, 6 and 12 hrs post START of dosing.
Interventions
- DRUG ME1100 inhalation solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01961830 record still lists
NCT01961830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which ME1100 inhalation solution is the first listed.
NCT01961830 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01961830 about?
NCT01961830 is a clinical study titled "Intrapulmonary Pharmacokinetics of ME1100 in Healthy Volunteers". This is a single-center, open-label, single-dose study. The primary objective is to determine Epithelial Lining Fluid (ELF) levels of ME1100 after a single orally inhaled dose. The secondary objectives are to determine systemic exposure to inhaled ME1100 and to assess tolerability and safety of a si...
What is the current status of trial NCT01961830?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2013-09.
What interventions are being tested in trial NCT01961830?
The interventions under investigation include: ME1100 inhalation solution (DRUG).
Who is sponsoring clinical trial NCT01961830?
This trial is sponsored by Meiji Seika Pharma Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01961830's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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