Clinical trial NCT03533387: Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers
Official title: Bioequivalence Study of Two MN-166 (Ibudilast) 50 mg Extended Release Tablet Formulations Compared With MN-166 (Ibudilast) 10mg Capsules in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: MediciNova
Sponsor class: INDUSTRY
First posted: 2018-05-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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).
Primary purpose: OTHER

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

Detailed description: Part 1:

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; and To choose one of the two MN-166 50mg ER tablet formulations for evaluation in Part 2.

Secondary: To determine the safety and tolerability of the two formulations of MN-166 ER tablets in a single-dose regimen in healthy volunteers.

Part 2:

To compare the bioavailability and steady-state pharmacokinetic profile of MN-166 50mg ER tablet with MN-166 10mg capsules in a multiple-dose regimen in healthy volunteers; and

Secondary: To determine the safety and tolerability of MN-166 ER tablets in a multiple-dose regimen in healthy volunteers

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Compare the PK Profile of two new formulations in Single-day dose of MN-166
timeFrame: 5 weeks
Secondary outcomes:
measure: Compare the incidence of treatment-emergent adverse events of two new formulations in Single-day dose of MN-166
timeFrame: 5 weeks
measure: Compare the PK Profile of two new formulations in Multi-day dose of MN-166
timeFrame: 3 weeks
measure: Compare the incidence of treatment-emergent adverse events of two new formulations in Multi-day dose of MN-166
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global, Inc.
state: California
Study officials:
affiliation: WCCT Global, Inc.
name: Robina Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: