Relapsing Remitting Multiple SclerosisPhase 1NCT04570670
Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects
A Phase 1 study testing monomethyl fumarate 190 mg and dimethyl fumarate 240 mg in people with Relapsing Remitting Multiple Sclerosis, run by Banner Life Sciences LLC.
Trial summary
The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg based on the Cmax and Area Under the Curve (AUC) values of monomethyl fumarate (MMF) determined after a single dose under fasting… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- monomethyl fumarate 190 mg and dimethyl fumarate 240 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2017to 17 Feb 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Continuous non-smoker who had not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study.
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2 at Screening.
- Medically healthy as determined by the Investigator or designee with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator or designee.
- Females of childbearing potential: not pregnant and either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or using one of the following acceptable birth control methods: hormonal oral contraceptives, vaginal ring, transdermal patch, or nonhormone or hormone releasing intrauterine device for at least 3 months prior to the first dose with either a physical (e.g., condom, diaphragm, or other) or a chemical (e.g., spermicide) barrier method from the time of Screening and throughout the study; depot/implantable hormone (e.g., Depo Provera®, Implanon®) for at least 3 months prior to the first dose and throughout the study.
- In addition, female subjects of childbearing potential were advised to remain sexually inactive or to keep the same birth control method for at least 7 days following the last dose.
- Females of non-childbearing potential: had undergone one of the following sterilization procedures at least 6 months prior to the first dose: hysteroscopic sterilization; bilateral tubal ligation or bilateral salpingectomy; hysterectomy; bilateral oophorectomy or were postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status as per Investigator's or designee's judgment.
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- Non-vasectomized male subjects agreed to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug. (No restrictions were required for a vasectomized male provided his vasectomy had been performed 4 months or more prior to the first dose of study drug. A male who had been vasectomized less than 4 months prior to the first dose of study drug, followed the same restrictions as a non-vasectomized male.)
- Males agreed not to donate sperm from the first dose until 90 days after dosing.
- Understood the study procedures in the Informed Consent Form (ICF), and were willing and able to comply with the protocol.
Who cannot join
- Subject was mentally or legally incapacitated or had significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
- History of any illness that, in the opinion of the Investigator or designee, might have confounded the results of the study or posed an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- Female subjects with a positive serum pregnancy test at Screening or Check-in, or who were lactating.
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- Positive urine drug, alcohol, or cotinine results at Screening or Check-in.
- Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure was less than 90/40 mmHg or greater than 140/90 mmHg at Screening.
- Seated heart rate was lower than 40 beats per minute (bpm) or higher than 99 bpm at Screening.
- Abnormal 12-lead ECG deemed clinically significant by the Investigator or designee at Screening or prior to the first dose.
- Unable to refrain from or anticipated the use of any drug, including prescription and non-prescription medications, or herbal remedies, beginning 14 days prior to the first dose and throughout the study. Medication listed as part of acceptable birth control methods was allowed. Hormone replacement therapy was also allowed. Acetaminophen (up to 2 g per 24-hour period) may have been permitted, as necessary during the study.
- Had been on a diet incompatible with the on study diet, in the opinion of the Investigator or designee, within the 28 days prior to the first dose and throughout the study.
- Donation of blood or significant blood loss within 30 days prior to the first dose.
- Plasma donation within 7 days prior to the first dose.
- Participation in another clinical study within 28 days prior to the first dose. The 28-day window was derived from the date of the last blood collection or dosing, whichever was later, in the previous study to Day 1 of Period 1 of the current study.
About this study
Official title: A Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting Conditions
The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg based on the Cmax and Area Under the Curve (AUC) values of monomethyl fumarate (MMF) determined after a single dose under fasting conditions.
Read the detailed description
This was a single-dose, open-label, randomized, 2-way crossover study, evaluating the comparative pharmacokinetics of the test product (MMF) versus the reference product (DMF) under fasting conditions. Fifty (50) healthy, adult male and non-pregnant female subjects were enrolled. Screening of subjects occurred within 21 days prior to the first dose. Subjects were randomized to 1 of 2 treatment sequences prior to the first dose.
In each period, subjects received a single oral dose of MMF 190 mg administered as two 95 mg delayed-release capsules (test product) or Tecfidera® 240 mg DMF delayed-release capsule (reference product), followed by blood sampling (including predose samples) up to 24 hours postdose for the determination of plasma concentrations of MMF. There was a washout period of 2 days between the 2 doses.
Safety was monitored throughout the study by repeated clinical and laboratory evaluations.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- monomethyl fumarate 190 mg, dimethyl fumarate 240 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
dimethyl fumarate 240 mgDrug
Also called Tecfidera
| Study group | Role | What they receive |
|---|---|---|
| Test (BLS-11) | Experimental | A single oral dose administration of BLS-11 190 mg (2 × 95 mg monomethyl fumarate delayed-release capsules) at Hour 0 on Day 1 Receives: Drug: monomethyl fumarate 190 mg |
| Reference (Tecfidera) | Active comparator | A single oral dose administration of Tecfidera 240 mg (1 × 240 mg dimethyl fumarate delayed-release capsule) at Hour 0 on Day 1 Receives: Drug: dimethyl fumarate 240 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, 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 the Cmax of MMF for each treatment.Venous blood samples were collected immediately prior to dosing, 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, 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 posted30 Sep 2020
- Study start6 Jan 2017
- Primary completion17 Feb 2017
- Study completion17 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Subjects were randomized to 1 of 2 treatment sequences prior to the first dose.
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT04570670
- Sponsor's protocol ID
- BLS-11-104
- Status last verified
- Mar 2022
- First submitted
- 22 Sep 2020
- Last updated
- 30 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lategan TW, Wang L, Sprague TN, Rousseau FS. Pharmacokinetics and Bioavailability of Monomethyl Fumarate Following a Single Oral Dose of Bafiertam (Monomethyl Fumarate) or Tecfidera(R) (Dimethyl Fumarate). CNS Drugs. 2021 May;35(5):567-574. doi: 10.1007/s40263-021-00799-9. Epub 2021 Mar 30.
PubMed 33797063
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04570670
- Acronym / sponsor ID
- BLS-11-104
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Banner Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 17 Feb 2017 (actual)
- Study completion
- 17 Feb 2017 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Posted 28 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg based on the Cmax and Area Under the Curve (AUC) values of monomethyl fumarate (MMF) determined after a single dose under fasting conditions.
Detailed description
This was a single-dose, open-label, randomized, 2-way crossover study, evaluating the comparative pharmacokinetics of the test product (MMF) versus the reference product (DMF) under fasting conditions. Fifty (50) healthy, adult male and non-pregnant female subjects were enrolled. Screening of subjects occurred within 21 days prior to the first dose. Subjects were randomized to 1 of 2 treatment sequences prior to the first dose.
In each period, subjects received a single oral dose of MMF 190 mg administered as two 95 mg delayed-release capsules (test product) or Tecfidera® 240 mg DMF delayed-release capsule (reference product), followed by blood sampling (including predose samples) up to 24 hours postdose for the determination of plasma concentrations of MMF. There was a washout period of 2 days between the 2 doses.
Safety was monitored throughout the study by repeated clinical and laboratory evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects were randomized to 1 of 2 treatment sequences prior to the first dose.
| Arm | Type | Receives |
|---|---|---|
| Test (BLS-11) | Experimental | Drug: monomethyl fumarate 190 mgA single oral dose administration of BLS-11 190 mg (2 × 95 mg monomethyl fumarate delayed-release capsules) at Hour 0 on Day 1 |
| Reference (Tecfidera) | Active comparator | Drug: dimethyl fumarate 240 mgA single oral dose administration of Tecfidera 240 mg (1 × 240 mg dimethyl fumarate delayed-release capsule) at Hour 0 on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Continuous non-smoker who had not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study.
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2 at Screening.
- Medically healthy as determined by the Investigator or designee with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator or designee.
- Females of childbearing potential: not pregnant and either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or using one of the following acceptable birth control methods: hormonal oral contraceptives, vaginal ring, transdermal patch, or nonhormone or hormone releasing intrauterine device for at least 3 months prior to the first dose with either a physical (e.g., condom, diaphragm, or other) or a chemical (e.g., spermicide) barrier method from the time of Screening and throughout the study; depot/implantable hormone (e.g., Depo Provera®, Implanon®) for at least 3 months prior to the first dose and throughout the study.
- In addition, female subjects of childbearing potential were advised to remain sexually inactive or to keep the same birth control method for at least 7 days following the last dose.
Key exclusion criteria (16 listed)
- Subject was mentally or legally incapacitated or had significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
- History of any illness that, in the opinion of the Investigator or designee, might have confounded the results of the study or posed an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
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-11 | Drug | Test (BLS-11) |
| dimethyl fumarate 240 mgAlso: Tecfidera | Drug | Reference (Tecfidera) |
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, 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 the Cmax of MMF for each treatment.Venous blood samples were collected immediately prior to dosing, 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, and 24 hours postdose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33797063Lategan TW, Wang L, Sprague TN, Rousseau FS. Pharmacokinetics and Bioavailability of Monomethyl Fumarate Following a Single Oral Dose of Bafiertam (Monomethyl Fumarate) or Tecfidera(R) (Dimethyl Fumarate). CNS Drugs. 2021 May;35(5):567-574. doi: 10.1007/s40263-021-00799-9. Epub 2021 Mar 30.
- Open AccessLink provided by the sponsor.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing monomethyl fumarate 190 mg and dimethyl fumarate 240 mg in people with Relapsing Remitting Multiple Sclerosis, run by Banner Life Sciences LLC.
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 9 inclusion and 16 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 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
On the ClinicalTrials.gov record for NCT04570670, which also lists 1 linked publication.
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 30 Dec 2022.