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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022473
• Other study ID #: BLS-11-109
• Status: Completed
• Phase: Phase 1
• Start date: July 7, 2019
• Est. completion date: October 19, 2019

Study information

• Verified date: January 2020
• Source: Banner Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 19, 2019
• Est. primary completion date: October 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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);

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Bafiertam
Over-encapsulated capsule to mask treatment
• Tecfidera
Over-encapsulated capsule to mask treatment

Locations

Country	Name	City	State
United States	BioPharma Services, Inc.	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Banner Life Sciences LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 weeks
Secondary	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).	5 weeks
Secondary	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	5 weeks
Secondary	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	5 weeks
Secondary	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.	5 weeks
Secondary	Safety and tolerability outcomes: incidence rates of all non GI-adverse events	Subject incidence rates of all non GI-adverse events	5 weeks