Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Extended-release formulation 1 (ER1) 50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release. |
Drug: 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 Names:
|
Experimental: Extended-release formulation 2 (ER2) 50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release. |
Drug: 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 Names:
|
Active Comparator: Intermediate-release formulation (IR) 10mg MN-166 capsule. This formulation is typically given two or three times daily, hence, the label of intermediate-release. |
Drug: 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Compare the PK Profile of two new formulations in Single-day dose of MN-166 [5 weeks]
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.
Secondary Outcome Measures
- Compare the incidence of treatment-emergent adverse events of two new formulations in Single-day dose of MN-166 [5 weeks]
Compare the number and frequency of treatment-emergent adverse events (serious and non-serious) 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.
- Compare the PK Profile of two new formulations in Multi-day dose of MN-166 [3 weeks]
Compare the maximum plasma concentrations [Cmax] of MN-166 of two different formula in a multiple-dose regimen.
- Compare the incidence of treatment-emergent adverse events of two new formulations in Multi-day dose of MN-166 [3 weeks]
Compare the number and frequency of treatment-emergent adverse events (serious and non-serious) of MN-166 (pharmacokinetic profiles) of two different formula in a multiple-dose regimen.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able to provide written informed consent.
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Healthy non-smoking male and female subjects aged 18 to 65 years, inclusive.
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No clinical abnormalities in laboratory and urine analyses.
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Normal renal function (GFR > 90mL/min).
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Liver enzymes should be less than twice the upper limit of normal (ULN).
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Screening electrocardiogram (ECG) with QT interval adjusted for heart rate within normal limits.
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Agree to use barrier contraceptive methods during the course of the study (hormonal contraceptive alone is not acceptable).
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Females of child-bearing potential must have a negative pregnancy test on Study Day 1.
Exclusion Criteria:
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Known hypersensitivity to Pinatos® or its components.
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Condition(s) which might affect drug absorption, metabolism or excretion.
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Untreated mental illness, current drug addiction or abuse or alcoholism.
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Donated blood in the past 90 days or have poor peripheral venous access.
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Platelets < l00,000/mm3, history of thrombocytopenia.
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Confirmed diagnosis of chronic liver disease, e.g., chronic Hep. B, Hep. C infection, auto-immune, alcoholic or neoplastic liver disease.
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Positive serostatus for HIV.
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Currently pregnant or nursing.
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History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric diseases.
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Received an investigational drug in the past 30 days.
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Unable to swallow tablets.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | WCCT Global, Inc. | Cypress | California | United States | 90630 |
Sponsors and Collaborators
- MediciNova
Investigators
- Principal Investigator: Robina Smith, MD, WCCT Global, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MN-166-HDT-001