NCT04054206

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

Relative Bioavailability Study of an Extended Release (ER) Tablet Formulation of MN-166 (Ibudilast) Compared to an Intermediate Release (IR) Capsule Formulation in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: MediciNova · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1, open-label, single-center study in at least 12 healthy volunteers or participants. Participants (at least n=2/sequence) meeting study eligibility and providing informed consent will be randomized to one of six treatment sequences. The three treatments of each sequence will be administered in a crossover fashion, separated by one week apart. Thus, participation in the study is 3 weeks long per participant. During each single-dose treatment, participants will check in the study facility the night before dosing and remain at the facility until 32 hours after dosing. For example, the participant would arrive at the study facility at 8:00 PM Sunday night, receive a single dose at 8:00 AM Monday morning, and blood samples will be taken prior to dosing and 30 minutes, 1, 2 4, 6, 8, 10, 12, 24, and 32 hours after dosing. After the 32-hour sample collection, participants may leave the study facility. Participants will return to the study facility for outpatient visits at each remaining PK sampling day (48, 72, and 96 hours after dosing) and after last treatment in each sequence. Participants will be discharged from the study after the last treatment.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	MN-166	MN-166 (ibudilast) is an orally available small molecule drug currently being investigated for human treatment in multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma, and alcohol and drug use disorders.

Timeline

• Start date: 2019-06-24
• Primary completion: 2019-07-17
• Completion: 2020-05-31
• First posted: 2019-08-13
• Last updated: 2020-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study