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NCT04054206 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability of MN-166 (Ibudilast) in Extended Release Tablet vs. Intermediate-release Capsule in Healthy Volunteers
A Phase 1 study, sponsored by MediciNova.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04054206: Completed Phase 1 study, sponsored by MediciNova.
NCT04054206 is a Phase 1 study that has completed, run by MediciNova. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04054206, a Phase 1 study, has completed, sponsored by MediciNova.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study will investigate the PK, relative bioavailability, safety, and tolerability of the extended release (ER) 50 mg MN-166 (ibudilast) tablet formulation as compared to the intermediate-release (IR) capsule formulation of MN-166 (ibudilast) and to examine the effect of food on the pharmacokinetics of the ER formulation.
Primary Outcome
Compare the maximum plasma concentrations (Cmax) of MN-166 (ibudilast) of ER 50 mg tablet and IR 10 mg capsule (5 capsules) formulations, in a single-dose regimen in healthy volunteers.
Interventions
- DRUG MN-166
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2020-05-31 |
| Phase | Phase 1 |
What the finished NCT04054206 record still lists
NCT04054206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which MN-166 is the first listed.
NCT04054206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04054206 about?
NCT04054206 is a clinical study titled "Relative Bioavailability of MN-166 (Ibudilast) in Extended Release Tablet vs. Intermediate-release Capsule in Healthy Volunteers". This study will investigate the PK, relative bioavailability, safety, and tolerability of the extended release (ER) 50 mg MN-166 (ibudilast) tablet formulation as compared to the intermediate-release (IR) capsule formulation of MN-166 (ibudilast) and to examine the effect of food on the pharmacokine...
What is the current status of trial NCT04054206?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-06-24. Estimated completion is 2020-05-31.
What interventions are being tested in trial NCT04054206?
The interventions under investigation include: MN-166 (DRUG).
Who is sponsoring clinical trial NCT04054206?
This trial is sponsored by MediciNova, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04054206's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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