Healthy VolunteersPhase 1NCT03533387
Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers
A Phase 1 study testing MN-166 in people with Healthy Volunteers, run by MediciNova at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MN-166
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 30 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent.
- Healthy non-smoking male and female subjects aged 18 to 65 years, inclusive.
- No clinical abnormalities in laboratory and urine analyses.
- Normal renal function (GFR > 90mL/min).
- Liver enzymes should be less than twice the upper limit of normal (ULN).
- Screening electrocardiogram (ECG) with QT interval adjusted for heart rate within normal limits.
- Agree to use barrier contraceptive methods during the course of the study (hormonal contraceptive alone is not acceptable).
- Females of child-bearing potential must have a negative pregnancy test on Study Day 1.
Who cannot join
- Known hypersensitivity to Pinatos® or its components.
- Condition(s) which might affect drug absorption, metabolism or excretion.
- Untreated mental illness, current drug addiction or abuse or alcoholism.
- Donated blood in the past 90 days or have poor peripheral venous access.
- Platelets < l00,000/mm3, history of thrombocytopenia.
- Confirmed diagnosis of chronic liver disease, e.g., chronic Hep. B, Hep. C infection, auto-immune, alcoholic or neoplastic liver disease.
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- Positive serostatus for HIV.
- Currently pregnant or nursing.
- History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric diseases.
- Received an investigational drug in the past 30 days.
- Unable to swallow tablets.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Healthy Volunteers
- Being tested
- MN-166
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MN-166Drug
Also called ibudilast, Pinatos® capsule
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
| Study group | Role | What they receive |
|---|---|---|
| Extended-release formulation 1 (ER1) | Experimental | 50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release. Receives: Drug: MN-166 |
| Extended-release formulation 2 (ER2) | Experimental | 50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release. Receives: Drug: MN-166 |
| Intermediate-release formulation (IR) | Active comparator | 10mg MN-166 capsule. This formulation is typically given two or three times daily, hence, the label of intermediate-release. Receives: Drug: MN-166 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (3)
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.
Measured: 5 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start11 Apr 2018
- Primary completion6 Jul 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediciNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robina Smith, MD, Principal investigator, WCCT Global, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533387
- Sponsor's protocol ID
- MN-166-HDT-001
- Status last verified
- May 2019
- First submitted
- 18 Apr 2018
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03533387
- Acronym / sponsor ID
- MN-166-HDT-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- MediciNovaIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Extended-release formulation 1 (ER1) | Experimental | Drug: MN-16650mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release. |
| Extended-release formulation 2 (ER2) | Experimental | Drug: MN-16650mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release. |
| Intermediate-release formulation (IR) | Active comparator | Drug: MN-16610mg MN-166 capsule. This formulation is typically given two or three times daily, hence, the label of intermediate-release. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to provide written informed consent.
- Healthy non-smoking male and female subjects aged 18 to 65 years, inclusive.
- No clinical abnormalities in laboratory and urine analyses.
- Normal renal function (GFR > 90mL/min).
- Liver enzymes should be less than twice the upper limit of normal (ULN).
Key exclusion criteria (11 listed)
- Known hypersensitivity to Pinatos® or its components.
- Condition(s) which might affect drug absorption, metabolism or excretion.
- Untreated mental illness, current drug addiction or abuse or alcoholism.
- Donated blood in the past 90 days or have poor peripheral venous access.
- Platelets < l00,000/mm3, history of thrombocytopenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MN-166Also: ibudilast, Pinatos® capsulean 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 | Drug | Extended-release formulation 1 (ER1), Extended-release formulation 2 (ER2), Intermediate-release formulation (IR) |
Primary outcome
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.
3 secondary outcomes
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 PK Profile of two new formulations in Multi-day dose of MN-166
Time frame: 3 weeks
Compare the incidence of treatment-emergent adverse events of two new formulations in Multi-day dose of MN-166
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robina Smith, MD principal investigator
WCCT Global, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MN-166 in people with Healthy Volunteers, run by MediciNova at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the PK Profile of two new formulations in Single-day dose of MN-166 (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.