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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT03533387

Run by

MediciNova

People needed

28

Starts

2018-04-11

Expected to finish

2018-09-30

Last updated by the study team

2019-05-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• WCCT Global, Inc. — Cypress, California, United States

Full record on ClinicalTrials.gov

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