Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects

NCT05181215 | Completed Phase 1 FDA Drug

• 1 other identifier: BLS-11-110
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

A single-dose, randomized, open-label, two-way crossover, two-period, two-sequence, two-treatment, single-center, bioequivalence study of Bafiertam and Vumerity.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• The Bioequivalent (BE) Comparison of AUC0-inf of Monomethyl Fumarate (MMF) Between Treatments

  Pharmacokinetics: Plasma concentrations of MMF will be determined and used to calculate AUC0-inf MMF for each treatment. Venous blood samples were collected immediately prior to dosing (time 0), and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 14, 16, 18, 20, 22, and 24 hours postdose.

  24 hours

• The BE Comparison of Cmax of Monomethyl Fumarate (MMF) Between Treatments

  Pharmacokinetics: Plasma concentrations of MMF will be determined and used to calculate Cmax of MMF for each treatment. Venous blood samples were collected immediately prior to dosing (time 0), and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 14, 16, 18, 20, 22, and 24 hours postdose.

  24 hours

Study Arms (2)

Bafiertam

EXPERIMENTAL

190 mg (2 x 95 mg) delayed-release capsules

Drug: Monomethyl Fumarate 190 Mg

Vumerity

ACTIVE COMPARATOR

462 mg (2 x 231 mg) delayed-release capsules

Drug: Diroximel Fumarate 462 mg

Interventions

Monomethyl Fumarate 190 Mg DRUG

2 x oral 95 mg capsules, delayed-release

Also known as: Bafiertam®, BLS-11

Bafiertam

Diroximel Fumarate 462 mg DRUG

2 x 231 mg capsules, delayed-release

Also known as: Vumerity®

Vumerity

Eligibility Criteria

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

You may qualify if:

• Healthy, non-smoking (at least for 6 months prior to first study drug administration) male and non-pregnant female volunteers, 18 years of age and older.
• BMI that is within 18.5-33.0 kg/m², inclusive.
• Healthy, according to the medical history, ECG, vital signs, laboratory results, and physical examination as determined by the PI/Sub-Investigator.
• Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50- 100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
• Clinical laboratory values within BPSUSA's most recent acceptable laboratory test range, and/or values are deemed by the PI/Sub-Investigator as "Not Clinically Significant".
• Ability to comprehend and be informed of the nature of the study, as assessed by BPSUSA staff. Capable of giving written informed consent prior to receiving any study medication. Must be able to communicate effectively with clinic staff.
• Ability to fast for at least 14 hours and consume standard meals.
• Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
• Agree not to have a tattoo or body piercing until the end of the study.
• Agree not to receive a vaccination (live attenuated vaccine) during the study and until 30 days after the study has ended (last study procedure).
• Agree not to drive or operate heavy machinery if feeling dizzy or drowsy following study drug administration until full mental alertness is regained.
• Female subjects must fulfill at least one of the following: Be surgically sterile for a minimum of 6 months; Post-menopausal for a minimum of 1 year; Agree to avoid pregnancy and use a medically acceptable method of contraception from at least 30 days prior to the study until 90 days after the study has ended (last study procedure).
• Male subjects who are able to father children must agree to use medically acceptable methods of contraception during the study and for 90 days after his last study drug administration.

You may not qualify if:

• Known history or presence of any clinically significant hepatic (e.g., hepatic impairment), renal/genitourinary (e.g., renal impairment), gastrointestinal, cardiovascular (supraventricular extrasystoles, atrioventricular block first degree, angina pectoris), 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 gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), 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 clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
• Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
• A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test and cotinine. Positive pregnancy test for female subjects.
• Known history or presence of: Alcohol or Drug abuse or dependence; Hypersensitivity or idiosyncratic reaction to monomethyl fumarate, diroximel fumarate, dimethyl fumarate, Bafiertam, Vumerity, their excipients, and/or related substances; Lymphocyte count \<1.5x 10\^9/L; Liver injury; Gastroenteritis; Protein in urine / Fanconi syndrome; Progressive multifocal leukoencephalopathy; Serious opportunistic infections, fungal infections; Food allergies and/or presence of any dietary restrictions unless deemed by the PI/Sub-I as "Not Clinically Significant"; Severe allergic reactions.
• Intolerance to and/or difficulty with blood sampling through venipuncture.
• Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets, etc.
• Individuals who have donated, in the days prior to first study drug administration: 50-499 mL of blood in the previous 30 days; 500 mL or more in the previous 56 days.
• Donation of plasma by plasmapheresis within 7 days prior to first study drug administration.
• Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first study drug administration.
• Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing and containing grapefruit and/or pomelo within 10 days prior to first study drug administration.
• Use of any prescription medication within 14 days prior to first study drug administration (except for hormonal contraceptives).
• Use of antineoplastic, immunosuppressive, or immune-modulating therapies and fumaric acid derivatives, nephrotoxic drugs within 14 days prior to first study drug administration.
• Use of any over-the-counter medications (including oral multivitamins, herbal, and/or dietary supplements) within 14 days prior to first study drug administration (except for spermicidal/barrier contraceptive products).

Sponsors & Collaborators

• Banner Life Sciences LLC: lead

Study Sites (1)

BioPharma Services, Inc.

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

monomethyl fumarate; diroximel fumarate

Condition Hierarchy (Ancestors)

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

Study Officials

• Franck Rousseau, MD

  Banner Life Sciences LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 6, 2022
• Study Start: May 14, 2021
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)