Cypress, California 90630

  • Healthy Volunteers

Purpose:

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


Study summary:

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


Criteria:

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 is Available At:


Original ID:

MN-166-HDT-001


NCT ID:

NCT03533387


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Bioequivalence Study of Two MN-166 (Ibudilast) 50 mg Extended Release Tablet Formulations Compared With MN-166 (Ibudilast) 10mg Capsules in Healthy Volunteers


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

MediciNova


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

28


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robina Smith, MD
Principal Investigator
WCCT Global, Inc.

Study Dates

Start Date:April 11, 2018
Completion Date:September 30, 2018
Completion Type:Actual
Primary Completion Date:July 6, 2018
Primary Completion Type:Actual
Verification Date:May 2019
Last Changed Date:May 29, 2019
First Received Date:April 18, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Compare the incidence of treatment-emergent adverse events of two new formulations in Multi-day dose of MN-166
Time Frame:3 weeks
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Compare the PK Profile of two new formulations in Multi-day dose of MN-166
Time Frame:3 weeks
Safety Issues:False
Description:Compare the maximum plasma concentrations [Cmax] of MN-166 of two different formula in a multiple-dose regimen.
Outcome Type:Secondary Outcome
Measure:Compare the incidence of treatment-emergent adverse events of two new formulations in Single-day dose of MN-166
Time Frame:5 weeks
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Compare the PK Profile of two new formulations in Single-day dose of MN-166
Time Frame:5 weeks
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:MN-166
Description: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
Arm Name:Extended-release formulation 1 (ER1)
Other Name:ibudilast

Study Arms

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

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:MediciNova

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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