Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers

NCT03533387 | Completed Phase 1 FDA Drug

• 1 other identifier: MN-166-HDT-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the bioavailability and pharmacokinetic profiles of two different formulations MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen in healthy volunteers

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Compare the PK Profile of two new formulations in Single-day dose of MN-166

  Compare the maximum plasma concentrations \[Cmax\] of MN-166 of two different formulations MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen in healthy volunteers.

  5 weeks

Secondary Outcomes (3)

• Compare the incidence of treatment-emergent adverse events of two new formulations in Single-day dose of MN-166

  5 weeks

• Compare the PK Profile of two new formulations in Multi-day dose of MN-166

  3 weeks

• Compare the incidence of treatment-emergent adverse events of two new formulations in Multi-day dose of MN-166

  3 weeks

Study Arms (3)

Extended-release formulation 1 (ER1)

EXPERIMENTAL

50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.

Drug: MN-166

Extended-release formulation 2 (ER2)

EXPERIMENTAL

50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.

Drug: MN-166

Intermediate-release formulation (IR)

ACTIVE COMPARATOR

10mg MN-166 capsule. This formulation is typically given two or three times daily, hence, the label of intermediate-release.

Drug: MN-166

Interventions

MN-166 DRUG

an orally available small molecule drug approved in Japan and Korea for asthma and post-stroke complications and has been prescribed for these indications for more than 25 years

Also known as: ibudilast, Pinatos® capsule

Extended-release formulation 1 (ER1); Extended-release formulation 2 (ER2); Intermediate-release formulation (IR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent.
• Healthy non-smoking male and female subjects aged 18 to 65 years, inclusive.
• No clinical abnormalities in laboratory and urine analyses.
• Normal renal function (GFR \> 90mL/min).
• Liver enzymes should be less than twice the upper limit of normal (ULN).
• Screening electrocardiogram (ECG) with QT interval adjusted for heart rate within normal limits.
• Agree to use barrier contraceptive methods during the course of the study (hormonal contraceptive alone is not acceptable).
• Females of child-bearing potential must have a negative pregnancy test on Study Day 1.

You may not qualify if:

• Known hypersensitivity to Pinatos® or its components.
• Condition(s) which might affect drug absorption, metabolism or excretion.
• Untreated mental illness, current drug addiction or abuse or alcoholism.
• Donated blood in the past 90 days or have poor peripheral venous access.
• Platelets \< l00,000/mm3, history of thrombocytopenia.
• Confirmed diagnosis of chronic liver disease, e.g., chronic Hep. B, Hep. C infection, auto-immune, alcoholic or neoplastic liver disease.
• Positive serostatus for HIV.
• Currently pregnant or nursing.
• History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric diseases.
• Received an investigational drug in the past 30 days.
• Unable to swallow tablets.

Sponsors & Collaborators

• MediciNova: lead

Study Sites (1)

WCCT Global, Inc.

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

ibudilast

Study Officials

• Robina Smith, MD

  WCCT Global, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will receive the following three treatments in a crossover fashion, administered one week apart: * ER1: Single dose (50mg) of ER Prototype 1 (one 50mg ER1 tablet), * ER2: Single dose (50mg) of ER Prototype 2 (one 50mg ER2 tablet), and * IR: Two doses of intermediate-release capsules (50mg Pinatos® capsules in two divided doses 12 hours apart, i.e., 25mg for each dose).

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 23, 2018
• Study Start: April 11, 2018
• Primary Completion: July 6, 2018
• Study Completion: September 30, 2018
• Last Updated: May 31, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)