Eligibility Details:
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
1. Subject is a man or non-pregnant, non-lactating woman, ≥ 18 and ≤ 55 years of age at
the time of signing the informed consent form (ICF).
2. Female subjects must meet at least 1 of the following criteria:
- Negative serum pregnancy test at Screening and Day -1 (females of child-bearing
potential [FCBP] only).
- Postmenopausal (defined as 2 years after the last period and follicle-stimulating
hormone [FSH] > 40 IU/L).
- Received surgical sterilization (eg, bilateral tubal ligation, bilateral
oophorectomy, hysterectomy) at least 6 months before Screening with medical
records.
3. Female subjects of child-bearing potential must agree to practice a highly effective
method of contraception throughout the study until completion of the follow-up phone
call. Highly effective methods of contraception are those that alone or in combination
result in a failure rate of a Pearl index of less than 1% per year when used
consistently and correctly. Acceptable methods of birth control in this study are the
following:
- Combined hormonal (oestrogen and progestogen containing) contraception, which may
be oral, intravaginal, or transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation,
which may be oral, injectable, implantable
- Placement of an intrauterine device or intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence Periodic abstinence (calendar, symptothermal, post-ovulation
methods), withdrawal (coitus interruptus), spermicides only, and lactational
amenorrhea method are not acceptable methods of contraception. Female condom and
male condom should not be used together.
4. Subject has a body weight of at least 110 pounds (50 kg); body mass index (BMI) within
the range of 18.0 to 30.0 kg/m2, inclusive (Screening and Day -1).
5. Subject is in good health, as determined by no clinically significant findings from
medical or surgical history, 12-lead ECG, physical examination, clinical laboratory
tests, and vital signs.
6. Subject must understand and voluntarily sign an ICF prior to any study-related
assessments/procedures being conducted.
7. Subject is willing and able to adhere to the study visit schedule and other protocol
requirements.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
1. Subject with a seated blood pressure outside 90 to 140 mmHg systolic or 50 to 90 mmHg
diastolic at Screening or Day -1.
2. Subject with a seated pulse rate outside 55 to 90 beats per minute (bpm) at Screening
or Day -1.
3. Subject has a presence or history of any abnormality or illness that, in the opinion
of the investigator, may affect absorption, distribution, metabolism, or elimination
of the IP (or would limit the subject's ability to participate in and complete this
clinical study.
4. Subject has any condition that confounds the ability to interpret data from the study.
5. Subject has a history of alcoholism, drug abuse, or addiction within 24 months prior
to Screening.
6. Subject has a positive serum test for human immunodeficiency virus (HIV), hepatitis B
virus (HBV), or hepatitis C virus (HCV).
7. Subject has used any tobacco- or nicotine-containing products (including but not
limited to cigarettes, pipes, cigars, electronic cigarettes, vape, chewing tobacco,
nicotine patches, nicotine lozenges, or nicotine gum) or marijuana (cigarette, joint,
vape, edibles, etc) within 3 months prior to the first dose of IP.
8. Subject has a positive urine drug test including cotinine at Screening or Day -1.
9. Subject has a positive alcohol urine or breath test at Screening or Day -1.
10. Subject has received any investigational drug within 30 days or 5 times the
elimination half-life (if known), whichever is longer, prior to the first dose of IP.
11. Subject has used any systemic over-the-counter medication (excluding acetaminophen up
to 1 g/day), dietary or herbal supplement (excluding vitamins/multivitamins) within 7
days prior to the first dose of IP. Herbal supplements including St. John's wort must
be discontinued at least 28 days prior to the first dose of IP.
12. Subject has consumed pomelo-variety citrus fruits or juice (including pomelo,
grapefruit, Seville oranges) within 7 days prior to the first dose of IP.
13. Subject has used any systemic prescription medication (excluding hormonal
contraceptives) within 28 days or 5 times the elimination half-life, whichever is
longer, prior to the first dose of IP.
14. Subject has ingested alcohol within 7 days prior to the first dose of IP.
15. Subject fails or is unwilling to abstain from strenuous physical activities for at
least 24 hours prior to the first dose of IP.
16. Subject has poor peripheral venous access.
17. Subject has donated greater than 400 mL of blood within 60 days prior to Day 1.
18. Subject has history of hypersensitivity or allergic reaction to sphingosine
1-phosphate (S1P) receptor modulators or cyclosporine.
19. Subject with history of any medical condition or medical history that, in the opinion
of the investigator, might confound the results of the study or jeopardize the safety
or welfare of the subject.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
