Multiple SclerosisPhase 1NCT04022473
Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers
A Phase 1 study testing Bafiertam and Tecfidera in people with Multiple Sclerosis, run by Banner Life Sciences LLC at 1 site in United States.
Trial summary
The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Bafiertam and Tecfidera
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2019to 19 Oct 2019
- 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
- Males or non-pregnant females.
- Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
- Body Mass Index within 18.0 - 34.0 kg/m2, inclusive
Who cannot join
- Known history or presence of any clinically significant hepatic, renal/genitourinary, Gastrointestinal (GI), cardiovascular, 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 GI pathology unresolved GI symptoms, 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 significant physical or organ abnormality as determined by the PI/Sub-Investigator.
- Subject with abnormal baseline laboratory values deemed to be clinically significant by the Investigator.
- Lymphocyte count <1.5x 10^9/L.
- Known history or presence of: Alcohol abuse or dependence within one year prior to first study drug administration; Drug abuse or dependence; Hypersensitivity or idiosyncratic reaction to DMF, its excipients, and/or related substances; Progressive multifocal leukoencephalopathy (PML); Fanconi syndrome; Flushing (e.g., warmth, redness, itching, and burning sensation); Low white blood cell count (lymphopenia);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind Study to Compare Gastrointestinal Tolerability Following Oral Administration of Bafiertam™ (Monomethyl Fumarate) or Tecfidera® (Dimethyl Fumarate) to Healthy Male and Female Volunteers
The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate).
Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and Tecfidera® when administered orally following bioequivalent dose regimens in healthy subjects.
Read the detailed description
Subjects randomized (1:1) to either Bafiertam (monomethyl fumarate) or Tecfidera (dimethyl fumarate) will enter a double-blind titration period where they will receive either Bafiertam 95 mg twice daily (BID) or Tecfidera 120 mg BID for 7 days. Following the titration period, they will enter a maintenance period in which they will receive Bafiertam 190 mg BID or Tecfidera 240 mg BID for 4 weeks.
- Conditions
- Multiple Sclerosis
- Being tested
- Bafiertam, Tecfidera
- Keywords
- Gastrointestinal
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BafiertamDrug
Also called monomethyl fumarate
Over-encapsulated capsule to mask treatment
TecfideraDrug
Also called dimethyl fumarate
Over-encapsulated capsule to mask treatment
| Study group | Role | What they receive |
|---|---|---|
| Bafiertam | Experimental | oral capsules administered twice daily Receives: Drug: Bafiertam |
| Tecfidera | Active comparator | oral capsules administered twice daily Receives: Drug: Tecfidera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) in each of the individual symptoms over the treatment period.
The symptoms measured are (1) nausea, (2) vomiting, (3) diarrhea, (4) upper abdominal pain, (5) lower abdominal pain, (6) constipation, (7) bloating, and (8) flatulence
Measured: 5 weeks
Secondary outcomes (5)
Comparison of the Modified Overall Gastrointestinal Symptom Scale (MOGISS) composite score
The MOGISS assesses global GI events (defined as one or more of the following symptoms: nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, constipation, bloating, and flatulence) and their effect on the patient during the 24 hours before each morning dose. The events items are rated on a 10-point numerical rating scale, where 0 = no events, 1 to 3 = mild events, 4 to 6 = moderate events, 7 to 9 = severe events, and 10 = extreme events. The MOGISS Total (sum of 8 scores) range is 0 (no symptoms) to 80 (worst possible symptoms) and the MOGISS Composite (average of 8 scores) range is 0 (no symptoms) - 10 (worst possible symptoms).
Measured: 5 weeks
The number of days that a subject experiences at least one GI symptom.
Number of days with at (as reported on the MOGISS) with a severity score of at least 1
Measured: 5 weeks
AUC in the MOGISS total score within in each subject over the treatment period
Defined as the daily total of all 8 individual symptom scores within each subject
Measured: 5 weeks
Frequency, severity, and duration of overall GI events using the MOGISS.
Frequency, severity and duration of overall GI events will be completed using the MOGISS for each week of study treatment as well as for the overall study treatment period.
Measured: 5 weeks
Safety and tolerability outcomes: incidence rates of all non GI-adverse events
Subject incidence rates of all non GI-adverse events
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start7 Jul 2019
- Primary completion19 Oct 2019
- Study completion19 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banner Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Doisy, MD, Principal investigator, BioPharma Services Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022473
- Sponsor's protocol ID
- BLS-11-109
- Status last verified
- Jan 2020
- First submitted
- 15 Jul 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study to Compare Gastrointestinal Tolerability Following Oral Administration of Bafiertam™ (Monomethyl Fumarate) or Tecfidera® (Dimethyl Fumarate) to Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT04022473
- Acronym / sponsor ID
- BLS-11-109
- Conditions
- Multiple Sclerosis
- Keywords
- Gastrointestinal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Banner Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2019 (actual)
- Primary completion
- 19 Oct 2019 (actual)
- Study completion
- 19 Oct 2019 (actual)
- First posted
- 17 Jul 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.
The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate).
Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and Tecfidera® when administered orally following bioequivalent dose regimens in healthy subjects.
Detailed description
Subjects randomized (1:1) to either Bafiertam (monomethyl fumarate) or Tecfidera (dimethyl fumarate) will enter a double-blind titration period where they will receive either Bafiertam 95 mg twice daily (BID) or Tecfidera 120 mg BID for 7 days. Following the titration period, they will enter a maintenance period in which they will receive Bafiertam 190 mg BID or Tecfidera 240 mg BID for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bafiertam | Experimental | Drug: Bafiertamoral capsules administered twice daily |
| Tecfidera | Active comparator | Drug: Tecfideraoral capsules administered twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or non-pregnant females.
- Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
- Body Mass Index within 18.0 - 34.0 kg/m2, inclusive
Key exclusion criteria (6 listed)
- Known history or presence of any clinically significant hepatic, renal/genitourinary, Gastrointestinal (GI), cardiovascular, 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 GI pathology unresolved GI symptoms, 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 significant physical or organ abnormality as determined by the PI/Sub-Investigator.
- Subject with abnormal baseline laboratory values deemed to be clinically significant by the Investigator.
- Lymphocyte count <1.5x 10^9/L.
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 |
|---|---|---|
| BafiertamAlso: monomethyl fumarateOver-encapsulated capsule to mask treatment | Drug | Bafiertam |
| TecfideraAlso: dimethyl fumarateOver-encapsulated capsule to mask treatment | Drug | Tecfidera |
Primary outcome
Area Under the Curve (AUC) in each of the individual symptoms over the treatment period.
Time frame: 5 weeks
The symptoms measured are (1) nausea, (2) vomiting, (3) diarrhea, (4) upper abdominal pain, (5) lower abdominal pain, (6) constipation, (7) bloating, and (8) flatulence
5 secondary outcomes
Comparison of the Modified Overall Gastrointestinal Symptom Scale (MOGISS) composite score
Time frame: 5 weeks
The number of days that a subject experiences at least one GI symptom.
Time frame: 5 weeks
AUC in the MOGISS total score within in each subject over the treatment period
Time frame: 5 weeks
Frequency, severity, and duration of overall GI events using the MOGISS.
Time frame: 5 weeks
Safety and tolerability outcomes: incidence rates of all non GI-adverse events
Time frame: 5 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 18 Jan 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Kathleen Doisy, MD principal investigator
BioPharma Services 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 Bafiertam and Tecfidera in people with 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 3 inclusion and 6 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 18 Jan 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?
Area Under the Curve (AUC) in each of the individual symptoms over the treatment period. (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 18 Jan 2020.