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

NCT04022473 | Completed Phase 1 FDA Drug

• 1 other identifier: BLS-11-109
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Gastrointestinal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comparison of the Modified Overall Gastrointestinal Symptom Scale (MOGISS) composite score

  5 weeks

• The number of days that a subject experiences at least one GI symptom.

  5 weeks

• AUC in the MOGISS total score within in each subject over the treatment period

  5 weeks

• Frequency, severity, and duration of overall GI events using the MOGISS.

  5 weeks

• Safety and tolerability outcomes: incidence rates of all non GI-adverse events

  5 weeks

Study Arms (2)

Bafiertam

EXPERIMENTAL

oral capsules administered twice daily

Drug: Bafiertam

Tecfidera

ACTIVE COMPARATOR

oral capsules administered twice daily

Drug: Tecfidera

Interventions

Bafiertam DRUG

Over-encapsulated capsule to mask treatment

Also known as: monomethyl fumarate

Bafiertam

Tecfidera DRUG

Over-encapsulated capsule to mask treatment

Also known as: dimethyl fumarate

Tecfidera

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• Banner Life Sciences LLC: lead

Study Sites (1)

BioPharma Services, Inc.

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

monomethyl fumarate; Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Kathleen Doisy, MD

  BioPharma Services Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: July 7, 2019
• Primary Completion: October 19, 2019
• Study Completion: October 19, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)