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

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

Inclusion criteria

• 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.

Exclusion criteria

• 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.