Healthy VolunteersPhase 1NCT04054206

Relative Bioavailability of MN-166 (Ibudilast) in Extended Release Tablet vs. Intermediate-release Capsule in Healthy Volunteers

A Phase 1 study testing MN-166 in people with Healthy Volunteers, run by MediciNova at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will investigate the PK, relative bioavailability, safety, and tolerability of the extended release (ER) 50 mg MN-166 (ibudilast) tablet formulation as compared to the intermediate-release (IR) capsule formulation of MN-166 (ibudilast) and to examine the effect of food on the pharmacokinetics of the ER… Read more about this study

Who is it for?: Ages 18 to 45 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: 12 participants
Where: 1 siteUnited States
Study dates: 24 Jun 2019to 31 May 2020
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Able to provide written informed consent.
Healthy non-smoking male and female subjects aged 18 to 45 years, inclusive. Health status is determined by physical examination, medical history, no clinical abnormalities in laboratory and urine analyses, normal renal function, liver enzymes less than twice the upper limit of normal (ULN), and electrocardiogram (ECG) with QT interval adjusted for heart rate within normal limits at the screening visit.
A body mass index (BMI) of 18 kg/m2 or greater, but less than 36 kg/m2.
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 urine pregnancy test on Day 1. If post-menopausal female, follicle stimulating hormone (FSH) level > 40 IU/L.

Who cannot join

History of clinically significant drug allergy or anaphylaxis, including known hypersensitivity to Pinatos® or its components.
History of any condition(s) which might affect drug absorption, metabolism or excretion.
Clinical evidence or a history of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurologic, or other chronic disease as judged by the Investigator.
History of severe psychiatric disease, especially major depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.
History of severe cardiac disease [e.g., New York Heart Association (NYHA) Functional Class III or IV], myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases.
Estimated creatinine clearance outside the normal range (</= 80 mL/min) at screening.

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History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
Evidence of alcohol and/or drug abuse within one year of screening.
Positive results on screen for drugs of abuse or alcohol at screening visit or Day 0.
History within 1 year of screening visit, or current habit, of smoking more than 10 cigarettes per day or equivalent (>3 cigars or >3 pipes-full).
Donated blood in the past 90 days or have poor peripheral venous access.
Platelets < 100,000/mm3, history of thrombocytopenia.
Confirmed diagnosis of chronic liver disease, for example, chronic Hepatitis B, Hepatitis C infection, auto-immune, alcoholic or neoplastic liver disease.
Positive serostatus for HIV, HCV, or HBV.
Currently pregnant or nursing.
Male partners of females who are pregnant.
History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric disease.
Participation in a clinical study with an investigational drug, biologic, or device within 3 months before receiving study drug.
Used any systemic medications, including vitamins and over-the-counter items, during the 14 days (or five times the elimination half-life of the medication, whichever is longer) before receiving study drug or will require their use during the study. Metabolic inducers and herbal preparations, which have been shown to produce metabolic enzyme induction or inhibition, whether as teas or formulations, are prohibited 28 days before dosing. Paracetamol 3000 mg/day will be allowed up to 2 consecutive days before dosing and during the outpatient phase of the study, as needed.
Unable to swallow large tablets.

Trial locations and contacts

1 site in 1 country.

United States1 site

Collaborative Neuroscience Network
Garden Grove, California, 92845

Other trials in United States

About this study

Official title: Relative Bioavailability Study of an Extended Release (ER) Tablet Formulation of MN-166 (Ibudilast) Compared to an Intermediate Release (IR) Capsule Formulation in Healthy Volunteers

Read the detailed description

This is a Phase 1, open-label, single-center study in at least 12 healthy volunteers or participants.

Participants (at least n=2/sequence) meeting study eligibility and providing informed consent will be randomized to one of six treatment sequences. The three treatments of each sequence will be administered in a crossover fashion, separated by one week apart. Thus, participation in the study is 3 weeks long per participant.

During each single-dose treatment, participants will check in the study facility the night before dosing and remain at the facility until 32 hours after dosing. For example, the participant would arrive at the study facility at 8:00 PM Sunday night, receive a single dose at 8:00 AM Monday morning, and blood samples will be taken prior to dosing and 30 minutes, 1, 2 4, 6, 8, 10, 12, 24, and 32 hours after dosing. After the 32-hour sample collection, participants may leave the study facility. Participants will return to the study facility for outpatient visits at each remaining PK sampling day (48, 72, and 96 hours after dosing) and after last treatment in each sequence. Participants will be discharged from the study after the last treatment.

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
MN-166 (ibudilast) is an orally available small molecule drug currently being investigated for human treatment in multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma, and alcohol and drug use disorders.

Study groups in NCT04054206
Study group	Role	What they receive
Sequence 1	Active comparator	Two participants will be randomly assigned to sequence 1 comprising 3 treatments (ER fasted, ER fed, and IR fasted) in a crossover design, administered one week apart: Day 1-7: ER fasted; Day 8-15: ER fed Day 15-22: IR fasted Receives: Drug: MN-166
Sequence 2	Active comparator	Two participants will be randomly assigned to sequence 2 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: ER fed; Day 8-15: IR fasted; Day 15-22: ER fasted Receives: Drug: MN-166
Sequence 3	Active comparator	Two participants will be randomly assigned to sequence 3 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: IR fasted; Day 8-15: ER fasted; Day 15-22: ER fed Receives: Drug: MN-166
Sequence 4	Active comparator	Two participants will be randomly assigned to sequence 4 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: IR fasted; Day 8-15: ER fed; Day 15-22: ER fasted Receives: Drug: MN-166
Sequence 5	Active comparator	Two participants will be randomly assigned to sequence 5 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: ER fasted; Day 8-15: IR fasted; Day 15-22: ER fed Receives: Drug: MN-166
Sequence 6	Active comparator	Two participants will be randomly assigned to sequence 6 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: ER fed; Day 8-15: ER fasted; Day 15-22: IR fasted Receives: Drug: MN-166

What is being measured

The primary outcome is the main question the study is designed to answer.

Compare the pharmacokinetic profile of ER and IR formulations in single-dose administration of MN-166 (ibudilast)
Compare the maximum plasma concentrations (Cmax) of MN-166 (ibudilast) of ER 50 mg tablet and IR 10 mg capsule (5 capsules) formulations, in a single-dose regimen in healthy volunteers.
Measured: From the time of pre-dose (immediately prior to taking the assigned MN-166/ibudilast formulation) to 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72, 96, and 168 hours post-single treatment dose.
Compare the pharmacokinetic profile of ER and IR formulations in single-dose administration of MN-166 (ibudilast) under fed or fasting states
Cmax of MN-166 (ibudilast) of ER 50 mg tablet and IR 10 mg capsule (5 capsules) formulations, in a single-dose regimen in healthy volunteers fed a high-fat meal 1 hour prior to dosing or fasted 8 hours prior to dosing.
Measured: From the time of pre-dose (immediately prior to taking the assigned MN-166/ibudilast formulation under either feeding or fasting conditions) to 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72, 96, and 168 hours post-single treatment dose.

Secondary outcomes (3)

Number of healthy volunteers with treatment-related adverse events as assessed by CTCAE v.4.0
Compare the number and frequency of treatment-emergent adverse events (serious and non-serious) profiles of ER and IR formulations of MN-166 (ibudilast) in healthy volunteers.
Measured: From the time of pre-dose (immediately prior to taking the assigned MN-166/ibudilast formulation under either feeding or fasting conditions) to 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72, 96, and 168 hours post-single treatment dose.
Changes in physical exam results
Compare the number and frequency of clinically significant changes in physical exam results between ER and IR formulations of MN-166 (ibudilast) in healthy volunteers.The HV's general health (for example, appearance, presence of illness or injury; temperature, pulse, or heart rate indicative of a concurrent illness) will be assessed to determine whether or not to continue in the study.
Measured: From the night before single-dose treatment to 168 hours post-dose under fed and fasted conditions.
Number of participants with clinically significant abnormal laboratory results
Compare the frequency of clinically significant abnormal laboratory results of ER and IR formulations of MN-166 (ibudilast) in healthy volunteers under fed and fasted states.
Measured: From the night before single-dose treatment to 168 hours post-dose under fed and fasted conditions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 201931 May 2020

First posted13 Aug 2019
Study start24 Jun 2019
Primary completion17 Jul 2019
Study completion31 May 2020

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 12 healthy male and female participants (enrollment is 6 female and 6 male participants). Each enrolled/consented participant will be randomly assigned to 1 of 6 treatment sequences which consists of 3 treatments (ER fasted, ER fed, and IR fasted) in a crossover design, administered one week apart.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04054206
Sponsor's protocol ID: MN-166-HDT-002
Status last verified: Jul 2020
First submitted: 6 Aug 2019
Last updated: 15 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability Study of an Extended Release (ER) Tablet Formulation of MN-166 (Ibudilast) Compared to an Intermediate Release (IR) Capsule Formulation in Healthy Volunteers
ClinicalTrials.gov ID: NCT04054206
Acronym / sponsor ID: MN-166-HDT-002
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: MediciNovaIndustry (pharma, biotech, devices)
Study start: 24 Jun 2019 (actual)
Primary completion: 17 Jul 2019 (actual)
Study completion: 31 May 2020 (actual)
First posted: 13 Aug 2019 (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.

Detailed description

This is a Phase 1, open-label, single-center study in at least 12 healthy volunteers or participants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: 12 healthy male and female participants (enrollment is 6 female and 6 male participants). Each enrolled/consented participant will be randomly assigned to 1 of 6 treatment sequences which consists of 3 treatments (ER fasted, ER fed, and IR fasted) in a crossover design, administered one week apart.

Arm	Type	Receives
Sequence 1	Active comparator	Drug: MN-166Two participants will be randomly assigned to sequence 1 comprising 3 treatments (ER fasted, ER fed, and IR fasted) in a crossover design, administered one week apart: Day 1-7: ER fasted; Day 8-15: ER fed Day 15-22: IR fasted
Sequence 2	Active comparator	Drug: MN-166Two participants will be randomly assigned to sequence 2 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: ER fed; Day 8-15: IR fasted; Day 15-22: ER fasted
Sequence 3	Active comparator	Drug: MN-166Two participants will be randomly assigned to sequence 3 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: IR fasted; Day 8-15: ER fasted; Day 15-22: ER fed
Sequence 4	Active comparator	Drug: MN-166Two participants will be randomly assigned to sequence 4 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: IR fasted; Day 8-15: ER fed; Day 15-22: ER fasted
Sequence 5	Active comparator	Drug: MN-166Two participants will be randomly assigned to sequence 5 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: ER fasted; Day 8-15: IR fasted; Day 15-22: ER fed
Sequence 6	Active comparator	Drug: MN-166Two participants will be randomly assigned to sequence 6 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: ER fed; Day 8-15: ER fasted; Day 15-22: IR fasted

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Able to provide written informed consent.
Healthy non-smoking male and female subjects aged 18 to 45 years, inclusive. Health status is determined by physical examination, medical history, no clinical abnormalities in laboratory and urine analyses, normal renal function, liver enzymes less than twice the upper limit of normal (ULN), and electrocardiogram (ECG) with QT interval adjusted for heart rate within normal limits at the screening visit.
A body mass index (BMI) of 18 kg/m2 or greater, but less than 36 kg/m2.
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 urine pregnancy test on Day 1. If post-menopausal female, follicle stimulating hormone (FSH) level > 40 IU/L.

Key exclusion criteria (20 listed)

History of clinically significant drug allergy or anaphylaxis, including known hypersensitivity to Pinatos® or its components.
History of any condition(s) which might affect drug absorption, metabolism or excretion.
Clinical evidence or a history of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurologic, or other chronic disease as judged by the Investigator.
History of severe psychiatric disease, especially major depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.
History of severe cardiac disease [e.g., New York Heart Association (NYHA) Functional Class III or IV], myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases.

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 capsuleMN-166 (ibudilast) is an orally available small molecule drug currently being investigated for human treatment in multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma, and alcohol and drug use disorders.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

Compare the pharmacokinetic profile of ER and IR formulations in single-dose administration of MN-166 (ibudilast)
Time frame: From the time of pre-dose (immediately prior to taking the assigned MN-166/ibudilast formulation) to 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72, 96, and 168 hours post-single treatment dose.
Compare the maximum plasma concentrations (Cmax) of MN-166 (ibudilast) of ER 50 mg tablet and IR 10 mg capsule (5 capsules) formulations, in a single-dose regimen in healthy volunteers.
Compare the pharmacokinetic profile of ER and IR formulations in single-dose administration of MN-166 (ibudilast) under fed or fasting states
Time frame: From the time of pre-dose (immediately prior to taking the assigned MN-166/ibudilast formulation under either feeding or fasting conditions) to 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72, 96, and 168 hours post-single treatment dose.
Cmax of MN-166 (ibudilast) of ER 50 mg tablet and IR 10 mg capsule (5 capsules) formulations, in a single-dose regimen in healthy volunteers fed a high-fat meal 1 hour prior to dosing or fasted 8 hours prior to dosing.

3 secondary outcomes

Number of healthy volunteers with treatment-related adverse events as assessed by CTCAE v.4.0
Time frame: From the time of pre-dose (immediately prior to taking the assigned MN-166/ibudilast formulation under either feeding or fasting conditions) to 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72, 96, and 168 hours post-single treatment dose.
Changes in physical exam results
Time frame: From the night before single-dose treatment to 168 hours post-dose under fed and fasted conditions.
Number of participants with clinically significant abnormal laboratory results
Time frame: From the night before single-dose treatment to 168 hours post-dose under fed and fasted conditions.

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 15 Jul 2020.

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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.

David P Walling, PhD principal investigator

Collaborative Neuroscience Network, LLC

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 5 inclusion and 20 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 15 Jul 2020. 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 pharmacokinetic profile of ER and IR formulations in single-dose administration of MN-166 (ibudilast) (time frame: From the time of pre-dose (immediately prior to taking the assigned MN-166/ibudilast formulation) to 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72, 96, and 168 hours post-single treatment dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04054206.

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 15 Jul 2020.