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 pregnancy test results 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 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 FSH and estradiol levels at
screening;
- 4. Considered healthy by the Investigator, based on subject's reported medical
history, full PE, clinical laboratory tests, 12-lead ECG, and vital signs;
- 5. Normal liver function (AST/ALT < 1.5x ULN) and normal renal function (eGFR>
60mL/min/1.73 m2) as determined by Investigator following review of clinical
laboratory test results;
- 6. Non-smoker and no nicotine containing products (including e-cigarettes) within 6
months;
-- 7. Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less
than 50 kg;
- 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.
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. Reported or suspected malignancy;
- 3. Reported history of pancreatitis or gall stones;
- 4. Reported history of unexplained syncope, symptomatic hypotension or hypoglycemia;
- 5. Reported family history of long QTc syndrome;
- 6. Reported history of chronic diarrhea, malabsorption, unexplained weight loss, food
allergies or intolerance;
- 7. Poor venous access;
- 8. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg), or hepatitis C antibody;
- 9. Donated or lost >500ml of blood in the previous 3 months;
- 10. Taken an investigational drug or participated in a clinical trial within 3 months
(or 5 half-lives), whichever is longer;
- 11. Taken any prescription medications within 14 days or 5 half-lives (whichever is
longer) of the first dose of study drug;
- 12. Hospital admission or major surgery within 6 months prior to screening;
- 13. A reported history of prescription drug abuse, or illicit drug use within 9 months
prior to screening;
- 14. A reported history of alcohol abuse according to medical history within 9 months
prior to screening;
- 15. A positive screen for alcohol, drugs of abuse at screening or Day -1;
- 16. An unwillingness or inability to comply with food and beverage restrictions during
study participation;
- 17. Use of over-the-counter (OTC) medication within 7 days, and herbal supplements
(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)
- 18. 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
