| Eligibility |
Inclusion Criteria:
Volunteers meeting all of the following criteria will be considered for enrollment in the
study:
1. Availability for the entire study period 2. Motivated volunteer and absence of
intellectual problems likely to limit the validity of consent to participate in the study
or the compliance with protocol requirements; ability to cooperate adequately; ability to
understand and observe the instructions of the physician or designee 3. Male or female
volunteer 4. A female volunteer must meet one of the following criteria:
1. Physiological postmenopausal status, defined as the following:
1. no menses for at least one year (absence of menses should not be due to
lactational amenorrhea); and
2. FSH levels = 40 mIU/mL at screening; or
2. Surgical postmenopausal status, defined as the following:
1. bilateral oophorectomy; and
2. absence of menses for at least 3 months; and
3. FSH levels = 40 mIU/mL at screening; or
3. Hysterectomy with FSH levels = 40 mIU/mL at screening If the postmenopausal volunteer
has an FSH of < 40 mIU/mL, but meets the above criteria in either (1), (2) or (3) and
all the other inclusion criteria in section 5.2, the volunteer may be included in the
study if the estradiol serum level measured at screening is equal to or below 150
pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria,
inclusion of the volunteer will be based on medical judgment. 5. Volunteer aged of at
least 18 years but not older than 45 years 6. Volunteer with a BMI greater than or
equal to 18.50 kg/m2 and below 30.00 kg/m2 7. Volunteer with a minimum body weight of
at least 60 kg 8. Non- or ex-smokers; an ex-smoker being defined as someone who
completely stopped smoking and/or using tobacco/tobacco-containing products for at
least 6 months before day 1 of this study 9. Clinical laboratory values within the
laboratory's stated normal range; if not within this range, they must be without any
clinical significance 10. Have no clinically significant diseases captured in the
medical history or evidence of clinically significant findings on physical examination
and/or clinical laboratory evaluations (hematology, general biochemistry, ECG and
urinalysis) 11. Willingness to adhere to the protocol requirements as evidenced by the
informed consent form (ICF) duly read, signed and dated by the volunteer 12. Volunteer
agrees not to participate in another clinical study for up to 10 weeks following the
last drug administration The ICF must be signed by all volunteers prior to their
participation in the study.
Exclusion Criteria:
Volunteers presenting any of the following will not be included in the study:
1. Difficulty donating blood
2. Difficulty swallowing solids like tablets or capsules
3. Seated pulse rate less than 60 bpm or more than 100 bpm at screening
4. History of significant hypersensitivity to fingolimod or any related products
(including excipients of the formulations) as well as severe hypersensitivity
reactions (like angioedema) to any drugs
5. Presence of significant gastrointestinal, liver or kidney disease, or any other
conditions known to interfere with the absorption, distribution, metabolism or
excretion of drugs or known to potentiate or predispose to undesired effects
6. History of significant gastrointestinal, liver or kidney disease that may affect drug
bioavailability
7. History or presence of significant cardiovascular, respiratory, pulmonary, hepatic,
renal, gastrointestinal, ophthalmological, hematologic, neurological, psychiatric,
endocrine, immunologic or dermatologic disease
8. Suicidal tendency, history of or disposition to seizures, state of confusion,
clinically relevant psychiatric diseases or disorder
9. Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60
msec, QRS >110 msec and QTc > 440 msec)
10. History of using live attenuated vaccines within 56 days before day 1 of this study
11. Immunization with a vaccine within 28 days before day 1 of this study
12. Use of immunosuppressant in the 28 days before day 1 of this study
13. Maintenance therapy with any drug or significant history of drug dependency or alcohol
abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
14. Any clinically significant illness in the previous 28 days before day 1 of this study
15. Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450
(CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin,
fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP
enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and
St John's Wort), in the previous 28 days before day 1 of this study
16. Any history of latent or active tuberculosis and/or prophylaxis for tuberculosis
according to the TB Medical History screening questionnaire (see Appendix 1)
17. Positive tuberculin blood or skin test
18. Herpes IgG (Type 1) and/or IgG (Type 2) antibody levels that may predispose to
undesired effects, as per medical judgment
19. Positive urine screening of drugs of abuse
20. Positive alcohol breath test
21. Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B)(hepatitis
B)) or anti-Hepatitis C Virus (HCV (C)) tests
22. Females who are pregnant according to a positive pregnancy test
23. Volunteers who took an Investigational Product (in another clinical trial) with a long
half-life (=120 hours) in the previous 3 months before day 1 of this study
24. Volunteers who took an Investigational Product (in another clinical trial) with a
half-life less than 120 hours in the previous 28 days before day 1 of this study or
who have already participated in this clinical study
25. Volunteers who donated 50 mL or more of blood in the previous 28 days before day 1 of
this study
26. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical
studies, etc.) in the previous 56 days before day 1 of this study
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