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Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04022473
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Banner Life Sciences LLC

Brief 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).

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Bafiertam Drug: Tecfidera Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 7, 2019
Estimated Primary Completion Date : October 28, 2019
Estimated Study Completion Date : October 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bafiertam
oral capsules administered twice daily
Drug: Bafiertam
Over-encapsulated capsule to mask treatment
Other Name: monomethyl fumarate

Active Comparator: Tecfidera
oral capsules administered twice daily
Drug: Tecfidera
Over-encapsulated capsule to mask treatment
Other Name: dimethyl fumarate




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Comparison of the Modified Overall Gastrointestinal Symptom Scale (MOGISS) composite score [ Time Frame: 5 weeks ]
    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).

  2. The number of days that a subject experiences at least one GI symptom. [ Time Frame: 5 weeks ]
    Number of days with at (as reported on the MOGISS) with a severity score of at least 1

  3. AUC in the MOGISS total score within in each subject over the treatment period [ Time Frame: 5 weeks ]
    Defined as the daily total of all 8 individual symptom scores within each subject

  4. Frequency, severity, and duration of overall GI events using the MOGISS. [ Time Frame: 5 weeks ]
    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.

  5. Safety and tolerability outcomes: incidence rates of all non GI-adverse events [ Time Frame: 5 weeks ]
    Subject incidence rates of all non GI-adverse events



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males or non-pregnant females.
  2. Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
  3. Body Mass Index within 18.0 - 34.0 kg/m2, inclusive

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
  4. Subject with abnormal baseline laboratory values deemed to be clinically significant by the Investigator.
  5. Lymphocyte count <1.5x 10^9/L.
  6. 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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022473


Contacts
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Contact: Igor Grahovac +1 416 747 8484 ext 264 igrahovac@biopharmaservices.com

Locations
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United States, Missouri
BioPharma Services, Inc. Recruiting
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
Banner Life Sciences LLC
Investigators
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Principal Investigator: Kathleen Doisy, MD BioPharma Services, Inc

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Responsible Party: Banner Life Sciences LLC
ClinicalTrials.gov Identifier: NCT04022473     History of Changes
Other Study ID Numbers: BLS-11-109
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Time Frame: Beginning 6 months and ending 12 months following article publication.
Access Criteria:

Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

The stated purpose of the analysis as to be for individual participant data meta-analysis.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Banner Life Sciences LLC:
Gastrointestinal

Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs