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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533387
• Other study ID #: MN-166-HDT-001
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: May 2019
• Source: MediciNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 30, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• MN-166
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

Locations

Country	Name	City	State
United States	WCCT Global, Inc.	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
MediciNova

Country where clinical trial is conducted

United States, 

Outcome

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