| Eligibility |
Inclusion Criteria:
1. Male or female subjects of 18 to 50 years of age (inclusive)
2. Able to read, understand, sign, and date a written informed consent form (ICF) before
study participation at screening
3. Agree to use 2 highly effective methods of contraception, including at least one
barrier method
4. Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening
5. Judged to be in good health based on medical history, physical examination, and
routine laboratory measurements (i.e., without clinically relevant pathology)
6. Normal electrocardiogram (ECG) (12-lead), arterial blood pressure, and heart rate
within the normal standard range used by the study center or considered not clinically
significant by the Investigator and in agreement with the Sponsor
7. Able to understand and comply with protocol requirements and instructions and likely
to complete the study as planned
8. A female study subject of childbearing potential must agree to use one of the accepted
contraceptive method from Screening, during the study, and for at least 90 days after
the last dose of the study medication. Hormonal contraceptives alone will not be
considered an adequate method of contraception.
9. A female study subject must agree not to donate eggs (oocytes) during the study and
for at least 90 days after the last dose of the study medication
10. Females of non-childbearing potential who have undergone a sterilization procedure at
least 6 months prior to dosing with official documentation (e.g., hysteroscopic
sterilization, bilateral tubal ligation or bilateral salpingectomy, hysterectomy, or
bilateral oophorectomy) or become postmenopausal with amenorrhea for at least 1 year
prior to dosing and have follicle-stimulating hormone (FSH) serum levels consistent
with postmenopausal status as per Principal Investigator's judgment
11. Subjects are able and willing to consume a high-fat meal within a 30 minute timeframe
Exclusion Criteria:
1. History of any illness or condition that, in the opinion of the Investigator, might
confound the results of the study or pose additional risks in administering study drug to
the subjects
1. Smokers (subjects who have smoked within 6 months prior to screening or those subjects
with a positive result from the smoking screening assay)
2. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
pharmacokinetics of the study drug (except appendectomy and simple hernia repair).
3. Regular treatment with prescription medications. Subjects should have ended any
prescription medications at least 14 days before the first dosing of the study drug.
Potential subjects should only stop any prescribed medication at the direction of a
physician or qualified medical professional.
4. Regular treatment with nonprescription medications. Subjects should have ended any
nonprescription medications at least 14 days before the first dosing of the study
drug. Potential subjects should consult with a physician or qualified medical
professional before stopping any regular treatment with nonprescription medication.
5. Consumption of herbal medications, dietary supplements, and specific fruit products.
Subjects should have stopped consumption of herbal medications or dietary supplements
(e.g., St. John's Wort, ginkgo biloba, and garlic supplements), vitamins, and
grapefruit or grapefruit juice, or Seville oranges at least 14 days before the first
dosing of study drug.
6. History of drug or alcohol abuse or addiction within 2 years before the start of study
drug dosing, or a positive test results for alcohol or drugs of abuse, such as
amphetamine, barbiturate, benzodiazepine, cocaine, methadone, opiates, oxycodone,
phencyclidine, propoxyphene, cannabinoid (THC), MDMA (Ecstasy), methaqualone, and
tricyclic antidepressant (TCA).
7. Regular consumption of more than 2 units of alcoholic beverages per day or more than
14 units per week (1 unit of alcohol equals 1 pint [473 mL] of beer or lager, 1 glass
[125 mL] of wine, 25 mL shot of 40% spirit) before screening. Subjects may not consume
any alcohol from 72 hours before the first dosing of study drug through the completion
of the last PK sampling.
8. Consumption of an average of more than 5 servings per day of coffee, tea, chocolate,
cola, or other caffeinated or methyl xanthine beverages before screening. Subjects may
not consume any tea, coffee, chocolate, and other foods and beverages containing
caffeine and other methyl xanthine derivatives from 48 hours prior to dosing until the
collection of the last PK sample.
9. Participation in a clinical study involving administration of either an
investigational or a marketed drug within 2 months or 7 half-lives (whichever is
longer) before screening.
10. Blood donation or a significant loss of blood within 60 days of the start of study
drug dosing or donation of more than 1 unit of plasma within 7 days before screening.
11. Positive result at screening for any of the following infectious disease tests:
hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human
immunodeficiency virus antigen and antibody (HIV-1/2 Ag/Ab)
12. Illness within 5 days before the start of study drug dosing ("illness" is defined as
an acute [serious or non-serious] condition [e.g., the flu or the common cold])
13. History of any known relevant allergy/hypersensitivity (including allergy to the trial
medication or its excipients)
14. Women who are pregnant or breastfeeding
15. Subject who is judged not eligible for study participation by Investigator
16. Subject is at imminent risk of suicide (positive response to question 4 or 5 on the
C-SSRS) or had a suicide attempt within 6 months prior to the Screening visit
|
