| Eligibility |
Inclusion Criteria:
1. Willing and able to
a) communicate in English or Spanish b) provide written informed consent to take part
in the study c) be available for all visits and able and willing to comply with all
study procedural requirements
2. Male or female, non-smoker (no use of tobacco or nicotine products within 3 months
prior to screening), = 18 and = 55 years of age, with BMI > 18.5 and < 30.0 kg/m2 and
body weight within 50 kg and 100 kg for males and 45 kg and 100 kg for females.
3. Healthy, as defined by:
a) The absence of clinically significant illness or surgery within 4 weeks of dosing.
Subjects vomiting within 24 hours before the first study drug administration will be
carefully evaluated for possible illness/disease and inclusion is at the discretion of
the Investigator.
b) The absence of clinically significant history and condition of neurological,
endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric,
gastrointestinal, renal, hepatic, and metabolic disease
4. Women (sex at birth) Pre-menopausal women (not post-menopausal: absence of menses for
at least 12 months and a medical history consistent with menopause) engaging in
heterosexual sex that could lead to pregnancy must be willing to use an effective
method of contraception for 4 weeks prior to taking the study drug, throughout the
study and until 30 days following the last study drug intake: Acceptable methods are:
• condom used together with another barrier method (diaphragm or cervical cap with
spermicide), hormonal method started at least 8 weeks before dosing, or an IUD in
place for at least 8 weeks
• sterilization of participant or partner (male vasectomized for at least 6 months)
5. Men (sex at birth) Heterosexually active men are required to use an effective method
of contraception for 4 weeks prior to taking the study drug, throughout the study and
until 90 days following the last study drug intake: Acceptable methods are:
• condom used together with another barrier method (diaphragm or cervical cap with
spermicide), hormonal method started at least 8 weeks before dosing, or an IUD in
place for at least 8 weeks
• sterilization of participant or partner (male vasectomized for at least 6 months)
6. Male subjects must commit to not donate sperm until at least 90 days following study
drug administration even if vasectomized.
7. Male subjects of a pregnant partner must use a condom from study drug administration
until 90 days afterwards, even if the male partner has been vasectomized.
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Exclusion Criteria:
1. Any clinically significant abnormality at physical examination, clinically significant
abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV
found during medical screening
2. Evidence of hepatic or renal impairment including ALT and AST above 1.5 x ULN, total
bilirubin above 1.5 x ULN, or creatinine above 1.5 x ULN.
3. Positive urine cotinine or positive urine drug screen at screening or baseline
4. History of anaphylaxis, or history of moderate or worse allergic reaction to oral drug
excipients
5. History of clinically significant gastrointestinal diseases or surgery which might
influence drug absorption
6. Positive pregnancy test at screening or baseline
7. Received a COVID-19 vaccine within 7 days of the baseline visit
8. Positive COVID-19 PCR test at screening or baseline
9. Clinically significant ECG abnormalities (QTcF = 450 ms)
10. Clinically significant vital sign abnormalities (systolic blood pressure lower than 90
or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart
rate less than 50 or over 100 bpm) at screening or baseline. In cases of abnormal
vital signs, tests can be repeated at the investigator's discretion.
11. History of substance abuse within 6 months before admission (with the exception of
medically indicated marijuana), including alcohol
12. Use of an investigational drug or device or participation in an investigational study
within 30 days prior to admission
13. Use of medications in the timeframes specified below, with the exception of
medications exempted by the Investigator on a case-by-case basis because they are
judged unlikely to affect the PK profile of the study drug or subject safety (e.g.,
topical drug products without significant systemic absorption):
1. Prescription medications taken within 14 days prior to dosing
2. Over-the-counter and natural health products (including herbal remedies,
homeopathic and traditional medicines, probiotics, food supplements such as
vitamins, minerals amino acids, essential fatty acids, and protein supplements
used in sports) taken within 7 days prior to dosing, with the exception of the
occasional use of acetaminophen (up to 2 g daily)
3. Depot injection or implant of any drug within 3 months prior to dosing
4. Use of any drugs known to induce or inhibit hepatic drug metabolism (including
St. John's Wort [hypericin]) within 30 days prior to dosing.
14. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding
volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than
499 mL within 56 days prior to dosing
15. Breast feeding
16. Any reason which, in the opinion of the Investigator, would prevent the subject from
participating in the study
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