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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04022473
• Date of registration: 15/07/2019
• Prospective Registration: No
• Primary sponsor: Banner Life Sciences LLC
• Public title: Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers
• Scientific 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
• Date of first enrolment: July 7, 2019
• Target sample size: 210
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04022473
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Kathleen Doisy, MD
• Affiliation: BioPharma Services, Inc

Key inclusion & exclusion 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);



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Bafiertam

Drug: Tecfidera

Primary Outcome(s)

Area Under the Curve (AUC) in each of the individual symptoms over the treatment period. [Time Frame: 5 weeks]

Secondary Outcome(s)

AUC in the MOGISS total score within in each subject over the treatment period [Time Frame: 5 weeks]

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

The number of days that a subject experiences at least one GI symptom. [Time Frame: 5 weeks]

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

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

Secondary ID(s)

BLS-11-109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors