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

MediciNova

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: MN-166

Study type: Interventional

Funder types: Industry

Identifiers

NCT03533387

MN-166-HDT-001

Details and patient eligibility

About

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

Full 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

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 3 patient groups

Extended-release formulation 1 (ER1)

Experimental group

Description:

50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.

Treatment:

Drug: MN-166

Extended-release formulation 2 (ER2)

Experimental group

Description:

50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.

Treatment:

Drug: MN-166

Intermediate-release formulation (IR)

Active Comparator group

Description:

10mg MN-166 capsule. This formulation is typically given two or three times daily, hence, the label of intermediate-release.

Treatment:

Drug: MN-166