Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers
NCT ID: NCT03533387
Last Updated: 2019-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2018-04-11
2018-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
* 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).
OTHER
NONE
Study Groups
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Extended-release formulation 1 (ER1)
50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.
MN-166
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
Extended-release formulation 2 (ER2)
50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.
MN-166
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
Intermediate-release formulation (IR)
10mg MN-166 capsule. This formulation is typically given two or three times daily, hence, the label of intermediate-release.
MN-166
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
Interventions
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MN-166
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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MediciNova
INDUSTRY
Responsible Party
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Principal Investigators
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Robina Smith, MD
Role: PRINCIPAL_INVESTIGATOR
WCCT Global, Inc.
Locations
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WCCT Global, Inc.
Cypress, California, United States
Countries
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Other Identifiers
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MN-166-HDT-001
Identifier Type: -
Identifier Source: org_study_id