Eligibility Details:
Inclusion Criteria:
1. Are capable of giving informed consent and complying with study procedures;
2. Are between the ages of 18 and 55 years, inclusive;
3. Female subjects have a negative serum hCG or urine pregnancy test result at screening
and Day -1, and meet one of the following criteria:
1. Using a medically acceptable form of birth control for at least 1 month prior to
screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral,
patch, injectable or vaginal ring), implantable device (implantable rod or
intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral,
patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
2. Surgically sterile, with documentation, for at least 3 months prior to screening
by one of the following means:
- Bilateral tubal ligation
- Bilateral salpingectomy (with or without oophorectomy)
- Surgical hysterectomy
- Bilateral oophorectomy (with or without hysterectomy)
3. Postmenopausal, defined as the following:
- Last menstrual period greater than 12 months prior to screening
- Postmenopausal status confirmed by serum follicle stimulating hormone (FSH)
and estradiol levels at screening;
4. Considered healthy by the Investigator, based on subject's reported medical history,
full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
5. Normal renal function as determined by Investigator following review of clinical
laboratory test results;
6. Non-smoker or no more than 2 tobacco-containing including nicotine replacement
products in last 6 months;
7. Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and body weight not less than 50
kg; Subjects with BMI between 30 and 32 kg/m2 may be allowed to participate with the
sponsor's approval;
8. Willing and able to adhere to study restrictions and to be confined at the clinical
research center;
9. Male subjects with female partners of child-bearing potential must agree to use
condoms for the duration of the study and until 12 weeks after dosing with the study
drug and must refrain from donating sperm for this same period;
10. Ability to swallow and retain oral medication.
Exclusion Criteria:
1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal,
endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic,
immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the
Investigator;
2. Pregnant (as determined by pregnancy test result) and breastfeeding women;
3. Current and/or recent history (<30 days prior to screening and/or <45 days prior to
randomization) of a clinically significant bacterial, fungal, parasitic, or
mycobacterial infection;
4. Current clinically significant viral infection;
5. Evidence of latent or active tuberculosis, as well as recent exposure or live
vaccinations
6. History of malignancy, with the exception of cured basal cell or squamous cell
carcinoma of the skin;
7. History of pancreatitis or gall stones;
8. History of unexplained syncope, symptomatic hypotension or hypoglycemia;
9. Family history of long QTc syndrome; History or presence of an abnormal ECG, which, in
the investigator's opinion, is clinically significant. QTcF interval >440 msec for
males and >460 msec for females;
10. Resting pulse <45 bpm or >100 bpm at screening, only with Day -1 as PI judgement;
11. History of unstable ischemic heart disease or uncontrolled hypertension (blood
pressure >140/90 mm Hg at screening, only with Day -1 as PI judgement);
12. History of stomach or intestinal surgery, except that appendectomy and/or
cholecystectomy will be allowed;
13. History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or
intolerance;
14. Poor venous access;
15. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg), or hepatitis C antibody;
16. Donated or lost >500 ml of blood in the previous 3 months;
17. Taken any prescription medications within 7 days or 5 half-lives (whichever is longer)
of the first dose of study drug;
18. Hospital admission or major surgery within 6 months prior to screening;
19. A history of prescription drug abuse, or illicit drug use within 9 months prior to
screening;
20. A history of alcohol abuse according to medical history within 9 months prior to
screening;
21. A positive screen for alcohol or drugs of abuse at screening or Day -1;
22. An unwillingness or inability to comply with food and beverage restrictions during
study participation;
23. Use of over-the-counter (OTC) medication within 7 days, and herbal (including St
John's Wort, herbal teas, garlic extracts) within 7 days prior to dosing (Note: Use of
acetaminophen at <2 g/day is permitted until 24 hours prior to dosing);
24. Current treatment or treatment within 30 days or 5 half-lives (whichever is longer)
prior to the first dose of study medication with another investigational medication or
current enrollment in another investigational drug protocol;
25. Hemoglobin, WBC, or platelet count below the lower reference limit of the testing
laboratory. Absolute neutrophil count <2000 cells/uL;
26. Any condition or finding that in the Investigators opinion would put the subject or
study conduct at risk if the subject were to participate in the study
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
