NCT04054206 is a Phase 1 clinical trial of MN-166 in Healthy Volunteers, sponsored by MediciNova.

Who is sponsoring NCT04054206?

NCT04054206 is sponsored by MediciNova.

What drugs are being tested in NCT04054206?

Interventions in NCT04054206: MN-166.

What condition does NCT04054206 study?

NCT04054206 studies Healthy Volunteers.

Is NCT04054206 still recruiting?

NCT04054206 is currently completed. Last updated 15 July 2020.

Last reviewed 2020-07-15 · How we verify

NCT04054206

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Relative Bioavailability of MN-166 (Ibudilast) in Extended Release Tablet vs. Intermediate-release Capsule in Healthy Volunteers

Completed Phase 1 Last updated 15 July 2020

What this trial tests

Phase 1 trial testing MN-166 in Healthy Volunteers in 12 participants. Completed in 31 May 2020.

Timeline

24 June 2019

Primary endpoint
17 July 2019

31 May 2020

Quick facts

Lead sponsor	MediciNova
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	24 June 2019
Primary completion	17 July 2019
Estimated completion	31 May 2020
Sites	1 location across United States

Drugs / interventions tested

MN-166 — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

MediciNova — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Clinical Implication of Phosphodiesterase-4-Inhibition.
Schick MA, Schlegel N. · · 2022 · cited 56× · PMID 35163131 · DOI 10.3390/ijms23031209
The multifaced role of the macrophage migration inhibitory factor family in organ fibrosis.
Herkens L, Droste P, Boor P. · · 2025 · cited 1× · PMID 40445596 · DOI 10.1152/ajpcell.00198.2025

Verify or expand the search:

Other trials of MN-166

Trials testing the same drug.

NCT03782415 — Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma · Phase 1, PHASE2 · completed
NCT03533387 — Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers · Phase 1 · completed
NCT06743776 — Scalable Expanded Access With Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS · available

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other MediciNova trials

Trials by the same sponsor.

NCT05464784 — MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia · Phase 2 · active not recruiting
NCT04429555 — Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for · Phase 2 · completed
NCT03782415 — Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma · Phase 1, PHASE2 · completed
NCT03533387 — Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers · Phase 1 · completed
NCT02714036 — A Biomarker Study to Evaluate MN-166 in Subjects With Amyotrophic Literal Sclerosis (ALS) · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04054206 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MediciNova
Last refreshed: 15 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04054206.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing