Clinical trial NCT04022473: Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Gastrointestinal
Lead sponsor: Banner Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2019-07-17
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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);

Primary outcomes:
measure: Area Under the Curve (AUC) in each of the individual symptoms over the treatment period.
timeFrame: 5 weeks
Secondary outcomes:
measure: Comparison of the Modified Overall Gastrointestinal Symptom Scale (MOGISS) composite score
timeFrame: 5 weeks
measure: The number of days that a subject experiences at least one GI symptom.
timeFrame: 5 weeks
measure: AUC in the MOGISS total score within in each subject over the treatment period
timeFrame: 5 weeks
measure: Frequency, severity, and duration of overall GI events using the MOGISS.
timeFrame: 5 weeks
measure: Safety and tolerability outcomes: incidence rates of all non GI-adverse events
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: BioPharma Services, Inc.
state: Missouri
Study officials:
affiliation: BioPharma Services Inc.
name: Kathleen Doisy, MD
role: PRINCIPAL_INVESTIGATOR
References: