| Eligibility |
Inclusion Criteria:
1. Non-smoking, healthy male or female between the ages of 18 and 55 years (inclusive) at
the time of informed consent.
2. Body mass index (BMI) > 18 and = 29 kg/m2 at Screening.
3. Females must be of non-childbearing potential (eg, postmenopausal [defined as
cessation of all menstrual periods for at least 1 year confirmed by
follicle-stimulating hormone (FSH) test = 40 UI/L] or surgically sterile by total
hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).
4. Males who have not had a successful vasectomy and are partners of women of
childbearing potential must use, or their partners must use, a medically acceptable
method of contraception starting for at least 1 menstrual cycle prior to and
throughout the entire study period, and for 2 weeks after the last dose of study drug.
Those with partners using hormonal contraceptives must also use an additional approved
method of contraception, such as a condom with spermicide. Males who have had a
successful vasectomy (confirmed azoospermia, documentation needed) require no
additional contraception. No sperm donation is allowed during the study period and for
90 days after study drug discontinuation.
Exclusion Criteria:
1. Evidence of clinically significant cardiovascular, hepatic, gastrointestinal (GI),
renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or
abnormalities.
2. History of any GI surgery or any condition possibly affecting drug absorption (eg,
cholecystectomy, gastrectomy, achlorhydria, peptic ulcer disease, history of stomach
or intestinal surgery or resection, except appendectomy and hernia repair will be
allowed).
3. Clinically significant illness within 8 weeks or a clinically significant infection
within 4 weeks prior to the first dose.
4. Food allergy deemed clinically significant per PI.
5. Clinically significant deviation from normal in the physical examination, vital signs,
or clinical laboratory determinations at Screening or Day -1 Check-in (baseline).
6. Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at Screening
or Day -1 Check-in (baseline).
7. Clinically significant ECG abnormality, including a marked baseline prolongation of
QT/QTc interval (eg, repeated demonstration of a QTcF interval > 480 msec), or has a
family history of prolonged QTc syndrome or sudden death.
8. Gilbert's syndrome as indicated by total bilirubin >upper limit of normal (ULN) and
subsequent measurement of direct bilirubin is not within normal range.
9. History of smoking or use of nicotine-containing substances within the previous 2
months, as determined by medical history or subject's verbal report and confirmed by
cotinine test at Screening and Check-In for any one of the treatment periods.
10. History of drug or alcohol misuse within 6 months prior to Screening or a positive
urine drug test at Screening or Check-in for any one of the treatment periods.
11. Diagnosed with acquired immune deficiency syndrome (AIDS) or has performed tests that
are positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or
Hepatitis C virus (HCV).
12. Participated in a clinical study of other drug before screening, and the time since
the last use of other study drug is less than 5 times the half-life or 4 weeks,
whichever is longer, or the subject is currently enrolled in another clinical study.
13. Consumed grapefruit, starfruit, Seville oranges, or their products within 7 days prior
to the first dose.
14. Consumed herbal preparations/medications, including, but not limited to kava, ephedra
(ma huang), Ginkgo biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and
ginseng, within 7 days prior to the first dose.
15. Weight loss or gain of > 10% within 4 weeks prior to the first dose.
16. Received blood or blood products within 4 weeks, or donated blood or blood products
within 8 weeks prior to the first dose or donated double red cell within 16 weeks
prior to first dose.
17. Used any over-the-counter (OTC) medications or prescription drugs within 2 weeks prior
to the first dose.
18. Used CYP3A inducers (including St. John's wort) or inhibitors within 2 weeks before
Day 1.
19. Allergic to any of the study drugs or to any of their excipients.
20. Used a PPI within 4 days prior to the first dose or a histamine 2 (H2) receptor
antagonist (H2 blocker) within 2 days prior to the first dose.
21. Cannot abstain from using a PPI or an H2 blocker or locally acting antacids (eg,
Gaviscon, Gelusil, Maalox, Milk of Magnesia, Mylanta, Rolaids, Tums).
22. Any condition that would make him or her, in the opinion of the investigator or
sponsor, unsuitable for the study, or who, in the opinion of the investigator, is not
likely to complete the study for any reason.
23. Female subject is pregnant, lactating, or breastfeeding.
24. Cannot consume study designed high-fat meal due to diet restrictions or being
vegetarian/vegan.
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