Status:
COMPLETED
Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers
Lead Sponsor:
Banner Life Sciences LLC
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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). Se...
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 dai...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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);
Key Trial Info
Start Date :
July 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2019
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04022473
Start Date
July 7 2019
End Date
October 19 2019
Last Update
January 18 2020
Active Locations (1)
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1
BioPharma Services, Inc.
Columbia, Missouri, United States, 65201