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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: MN-166

• Registration Number: NCT03533387
• Lead Sponsor: MediciNova

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

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 Timeline

• Study Start: 2018-04-11
• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-05-10
• Study First Posted: 2018-05-23
• Primary Completion: 2018-07-06
• Study Completion: 2018-09-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-29
• Last Update Posted: 2019-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Extended-release formulation 1 (ER1)	MN-166	50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.
Intermediate-release formulation (IR)	MN-166	10mg MN-166 capsule. This formulation is typically given two or three times daily, hence, the label of intermediate-release.
Extended-release formulation 2 (ER2)	MN-166	50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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.
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.

Trial Locations

Locations (1)

WCCT Global, Inc.; 🇺🇸 Cypress, California, United States