Relapsing Remitting Multiple SclerosisPhase 1NCT05181215
Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects
A Phase 1 study testing Monomethyl Fumarate 190 Mg and Diroximel Fumarate 462 mg in people with Relapsing Remitting Multiple Sclerosis, run by Banner Life Sciences LLC at 1 site in United States.
Trial summary
A single-dose, randomized, open-label, two-way crossover, two-period, two-sequence, two-treatment, single-center, bioequivalence study of Bafiertam and Vumerity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Monomethyl Fumarate 190 Mg and Diroximel Fumarate 462 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 27 Aug 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-smoking (at least for 6 months prior to first study drug administration) male and non-pregnant female volunteers, 18 years of age and older.
- BMI that is within 18.5-33.0 kg/m², inclusive.
- Healthy, according to the medical history, ECG, vital signs, laboratory results, and physical examination as determined by the PI/Sub-Investigator.
- Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50- 100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
- Clinical laboratory values within BPSUSA's most recent acceptable laboratory test range, and/or values are deemed by the PI/Sub-Investigator as "Not Clinically Significant".
- Ability to comprehend and be informed of the nature of the study, as assessed by BPSUSA staff. Capable of giving written informed consent prior to receiving any study medication. Must be able to communicate effectively with clinic staff.
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- Ability to fast for at least 14 hours and consume standard meals.
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
- Agree not to have a tattoo or body piercing until the end of the study.
- Agree not to receive a vaccination (live attenuated vaccine) during the study and until 30 days after the study has ended (last study procedure).
- Agree not to drive or operate heavy machinery if feeling dizzy or drowsy following study drug administration until full mental alertness is regained.
- Female subjects must fulfill at least one of the following: Be surgically sterile for a minimum of 6 months; Post-menopausal for a minimum of 1 year; Agree to avoid pregnancy and use a medically acceptable method of contraception from at least 30 days prior to the study until 90 days after the study has ended (last study procedure).
- Male subjects who are able to father children must agree to use medically acceptable methods of contraception during the study and for 90 days after his last study drug administration.
Who cannot join
- Known history or presence of any clinically significant hepatic (e.g., hepatic impairment), renal/genitourinary (e.g., renal impairment), gastrointestinal, cardiovascular (supraventricular extrasystoles, atrioventricular block first degree, angina pectoris), cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first study drug administration, as determined by the PI/Sub-Investigator.
- Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
- Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
- A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test and cotinine. Positive pregnancy test for female subjects.
- Known history or presence of: Alcohol or Drug abuse or dependence; Hypersensitivity or idiosyncratic reaction to monomethyl fumarate, diroximel fumarate, dimethyl fumarate, Bafiertam, Vumerity, their excipients, and/or related substances; Lymphocyte count <1.5x 10^9/L; Liver injury; Gastroenteritis; Protein in urine / Fanconi syndrome; Progressive multifocal leukoencephalopathy; Serious opportunistic infections, fungal infections; Food allergies and/or presence of any dietary restrictions unless deemed by the PI/Sub-I as "Not Clinically Significant"; Severe allergic reactions.
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- Intolerance to and/or difficulty with blood sampling through venipuncture.
- Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets, etc.
- Individuals who have donated, in the days prior to first study drug administration: 50-499 mL of blood in the previous 30 days; 500 mL or more in the previous 56 days.
- Donation of plasma by plasmapheresis within 7 days prior to first study drug administration.
- Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first study drug administration.
- Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing and containing grapefruit and/or pomelo within 10 days prior to first study drug administration.
- Use of any prescription medication within 14 days prior to first study drug administration (except for hormonal contraceptives).
- Use of antineoplastic, immunosuppressive, or immune-modulating therapies and fumaric acid derivatives, nephrotoxic drugs within 14 days prior to first study drug administration.
- Use of any over-the-counter medications (including oral multivitamins, herbal, and/or dietary supplements) within 14 days prior to first study drug administration (except for spermicidal/barrier contraceptive products).
- Individuals having undergone any major surgery within 6 months prior to the start of the study unless deemed otherwise by PI/Sub-Investigator.
- Difficulty with swallowing the whole capsule.
- Women who are pregnant or lactating.
- Unable or unwilling to provide informed consent.
- Have had a tattoo or body piercing within 30 days prior to first study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Randomized, Open-Label, Two-Way Crossover, Bioequivalence Study of Bafiertam (Monomethyl Fumarate) 190 mg and Vumerity® (Diroximel Fumarate) 462 mg Delayed-Release Capsules in Fasting Healthy Male and Female Subjects
A single-dose, randomized, open-label, two-way crossover, two-period, two-sequence, two-treatment, single-center, bioequivalence study of Bafiertam and Vumerity.
Read the detailed description
A single-dose, randomized, open-label, two-way crossover, two-period, two-sequence, two-treatment, single-center to assess the bioequivalence of Bafiertam (Monomethyl Fumarate) 190 mg (administered as 2 x 95 mg) Delayed-Release Capsules and Vumerity® (Diroximel Fumarate) 462 mg (Administered as 2 x 231 mg) Delayed-Release Capsules as assessed by plasma monomethyl fumarate concentrations in 40 healthy, non-smoking, male, and non-pregnant female volunteers under fasting conditions.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Monomethyl Fumarate 190 Mg, Diroximel Fumarate 462 mg
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monomethyl Fumarate 190 MgDrug
Also called Bafiertam®, BLS-11
2 x oral 95 mg capsules, delayed-release
Diroximel Fumarate 462 mgDrug
Also called Vumerity®
2 x 231 mg capsules, delayed-release
| Study group | Role | What they receive |
|---|---|---|
| Bafiertam | Experimental | 190 mg (2 x 95 mg) delayed-release capsules Receives: Drug: Monomethyl Fumarate 190 Mg |
| Vumerity | Active comparator | 462 mg (2 x 231 mg) delayed-release capsules Receives: Drug: Diroximel Fumarate 462 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Bioequivalent (BE) Comparison of AUC0-inf of Monomethyl Fumarate (MMF) Between Treatments
Pharmacokinetics: Plasma concentrations of MMF will be determined and used to calculate AUC0-inf MMF for each treatment. Venous blood samples were collected immediately prior to dosing (time 0), and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 14, 16, 18, 20, 22, and 24 hours postdose.
Measured: 24 hours
The BE Comparison of Cmax of Monomethyl Fumarate (MMF) Between Treatments
Pharmacokinetics: Plasma concentrations of MMF will be determined and used to calculate Cmax of MMF for each treatment. Venous blood samples were collected immediately prior to dosing (time 0), and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 14, 16, 18, 20, 22, and 24 hours postdose.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start14 May 2021
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies 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
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banner Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franck Rousseau, MD, Study director, Banner Life Sciences LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181215
- Sponsor's protocol ID
- BLS-11-110
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2021
- Last updated
- 6 Jan 2022
- 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 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Open-Label, Two-Way Crossover, Bioequivalence Study of Bafiertam (Monomethyl Fumarate) 190 mg and Vumerity® (Diroximel Fumarate) 462 mg Delayed-Release Capsules in Fasting Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT05181215
- Acronym / sponsor ID
- BLS-11-110
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Banner Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 14 May 2021 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 6 Jan 2022 (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.
A single-dose, randomized, open-label, two-way crossover, two-period, two-sequence, two-treatment, single-center, bioequivalence study of Bafiertam and Vumerity.
Detailed description
A single-dose, randomized, open-label, two-way crossover, two-period, two-sequence, two-treatment, single-center to assess the bioequivalence of Bafiertam (Monomethyl Fumarate) 190 mg (administered as 2 x 95 mg) Delayed-Release Capsules and Vumerity® (Diroximel Fumarate) 462 mg (Administered as 2 x 231 mg) Delayed-Release Capsules as assessed by plasma monomethyl fumarate concentrations in 40 healthy, non-smoking, male, and non-pregnant female volunteers under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bafiertam | Experimental | Drug: Monomethyl Fumarate 190 Mg190 mg (2 x 95 mg) delayed-release capsules |
| Vumerity | Active comparator | Drug: Diroximel Fumarate 462 mg462 mg (2 x 231 mg) delayed-release capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy, non-smoking (at least for 6 months prior to first study drug administration) male and non-pregnant female volunteers, 18 years of age and older.
- BMI that is within 18.5-33.0 kg/m², inclusive.
- Healthy, according to the medical history, ECG, vital signs, laboratory results, and physical examination as determined by the PI/Sub-Investigator.
- Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50- 100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
- Clinical laboratory values within BPSUSA's most recent acceptable laboratory test range, and/or values are deemed by the PI/Sub-Investigator as "Not Clinically Significant".
Key exclusion criteria (20 listed)
- Known history or presence of any clinically significant hepatic (e.g., hepatic impairment), renal/genitourinary (e.g., renal impairment), gastrointestinal, cardiovascular (supraventricular extrasystoles, atrioventricular block first degree, angina pectoris), cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first study drug administration, as determined by the PI/Sub-Investigator.
- Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
- Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
- A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test and cotinine. Positive pregnancy test for female subjects.
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 |
|---|---|---|
| Monomethyl Fumarate 190 MgAlso: Bafiertam®, BLS-112 x oral 95 mg capsules, delayed-release | Drug | Bafiertam |
| Diroximel Fumarate 462 mgAlso: Vumerity®2 x 231 mg capsules, delayed-release | Drug | Vumerity |
Primary outcome
The Bioequivalent (BE) Comparison of AUC0-inf of Monomethyl Fumarate (MMF) Between Treatments
Time frame: 24 hours
Pharmacokinetics: Plasma concentrations of MMF will be determined and used to calculate AUC0-inf MMF for each treatment. Venous blood samples were collected immediately prior to dosing (time 0), and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 14, 16, 18, 20, 22, and 24 hours postdose.
The BE Comparison of Cmax of Monomethyl Fumarate (MMF) Between Treatments
Time frame: 24 hours
Pharmacokinetics: Plasma concentrations of MMF will be determined and used to calculate Cmax of MMF for each treatment. Venous blood samples were collected immediately prior to dosing (time 0), and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 14, 16, 18, 20, 22, and 24 hours postdose.
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 6 Jan 2022.
- 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.
Franck Rousseau, MD study director
Banner Life Sciences 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 Monomethyl Fumarate 190 Mg and Diroximel Fumarate 462 mg in people with Relapsing Remitting Multiple Sclerosis, run by Banner Life Sciences LLC 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 13 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 6 Jan 2022. 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?
The Bioequivalent (BE) Comparison of AUC0-inf of Monomethyl Fumarate (MMF) Between Treatments (time frame: 24 hours). 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?
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 6 Jan 2022.