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

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ClinicalTrials.gov Identifier: NCT03533387
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: MN-166 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Subjects will receive the following three treatments in a crossover fashion, administered one week apart:

  • ER1: Single dose (50mg) of ER Prototype 1 (one 50mg ER1 tablet),
  • ER2: Single dose (50mg) of ER Prototype 2 (one 50mg ER2 tablet), and
  • IR: Two doses of intermediate-release capsules (50mg Pinatos® capsules in two divided doses 12 hours apart, i.e., 25mg for each dose).
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : April 11, 2018
Actual Primary Completion Date : July 6, 2018
Actual Study Completion Date : September 30, 2018

Arm Intervention/treatment
Experimental: Extended-release formulation 1 (ER1)
50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.
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
Other Names:
  • ibudilast
  • Pinatos® capsule

Experimental: Extended-release formulation 2 (ER2)
50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.
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
Other Names:
  • ibudilast
  • Pinatos® capsule

Active Comparator: Intermediate-release formulation (IR)
10mg MN-166 capsule. This formulation is typically given two or three times daily, hence, the label of intermediate-release.
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
Other Names:
  • ibudilast
  • Pinatos® capsule




Primary Outcome Measures :
  1. Compare the PK Profile of two new formulations in Single-day dose of MN-166 [ Time Frame: 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 :
  1. Compare the incidence of treatment-emergent adverse events of two new formulations in Single-day dose of MN-166 [ Time Frame: 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.

  2. Compare the PK Profile of two new formulations in Multi-day dose of MN-166 [ Time Frame: 3 weeks ]
    Compare the maximum plasma concentrations [Cmax] of MN-166 of two different formula in a multiple-dose regimen.

  3. Compare the incidence of treatment-emergent adverse events of two new formulations in Multi-day dose of MN-166 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533387


Locations
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United States, California
WCCT Global, Inc.
Cypress, California, United States, 90630
Sponsors and Collaborators
MediciNova
Investigators
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Principal Investigator: Robina Smith, MD WCCT Global, Inc.
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Responsible Party: MediciNova
ClinicalTrials.gov Identifier: NCT03533387    
Other Study ID Numbers: MN-166-HDT-001
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ibudilast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents