| Eligibility |
Inclusion Criteria:
1. 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.
2. BMI that is within 18.5-33.0 kg/m², inclusive.
3. Healthy, according to the medical history, ECG, vital signs, laboratory results, and
physical examination as determined by the PI/Sub-Investigator.
4. 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.
5. 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".
6. 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.
7. Ability to fast for at least 14 hours and consume standard meals.
8. Availability to volunteer for the entire study duration and willing to adhere to all
protocol requirements.
9. Agree not to have a tattoo or body piercing until the end of the study.
10. Agree not to receive a vaccination (live attenuated vaccine) during the study and
until 30 days after the study has ended (last study procedure).
11. Agree not to drive or operate heavy machinery if feeling dizzy or drowsy following
study drug administration until full mental alertness is regained.
12. 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).
13. 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.
Exclusion Criteria:
1. 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.
2. 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.
3. Presence of any clinically significant illness within 30 days prior to first dosing,
as determined by the PI/Sub-Investigator.
4. Presence of any significant physical or organ abnormality as determined by the
PI/Sub-Investigator.
5. 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.
6. 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.
7. Intolerance to and/or difficulty with blood sampling through venipuncture.
8. Abnormal diet patterns (for any reason) during the four weeks preceding the study,
including fasting, high protein diets, etc.
9. 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.
10. Donation of plasma by plasmapheresis within 7 days prior to first study drug
administration.
11. Individuals who have participated in another clinical trial or who received an
investigational drug within 30 days prior to first study drug administration.
12. 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.
13. Use of any prescription medication within 14 days prior to first study drug
administration (except for hormonal contraceptives).
14. Use of antineoplastic, immunosuppressive, or immune-modulating therapies and fumaric
acid derivatives, nephrotoxic drugs within 14 days prior to first study drug
administration.
15. 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).
16. Individuals having undergone any major surgery within 6 months prior to the start of
the study unless deemed otherwise by PI/Sub-Investigator.
17. Difficulty with swallowing the whole capsule.
18. Women who are pregnant or lactating.
19. Unable or unwilling to provide informed consent.
20. Have had a tattoo or body piercing within 30 days prior to first study drug
administration
|
