| Eligibility |
Inclusion Criteria:
1. Capable of understanding the written informed consent document; willingly provides
valid, signed written informed consent; willing and able to comply with the schedule,
requirements, and restrictions of the study. Are capable of giving informed consent
and complying with study procedures.
2. Between the ages of 18 and 55 years (inclusive) at the time of Screening.
3. BMI between 18.0 and 32.0 kg/m2 (inclusive) at the time of Screening and have a body
weight no less than 50 kg.
4. In good general health, as determined by the Investigator.
5. Female subjects must be non pregnant and non lactating.
6. Female subjects must be of non childbearing potential, or agree to use an appropriate
method(s) of contraception throughout the entire duration of study participation, and
have negative pregnancy test results at Screening (serum) and Admission (urine).
Refer to Section 6.4.1 for full details of reproductive requirements and acceptable
methods of contraception for female subjects.
7. Male subjects with female partners of reproductive potential must agree to practice
abstinence or to use a condom (male subject) plus an additional barrier method (female
partner) of contraception for the duration of the study and for at least 90 days after
dosing; must also agree to refrain from sperm donation for at least 90 days post dose.
8. Normal renal function as determined by Investigator following review of clinical
laboratory test results, including eGFR as estimated using the CKD EPI equation.
9. Non smoker, with no use of any tobacco or nicotine containing products within 6 months
prior to Day 1.
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. Known or suspected malignancy.
3. History of pancreatitis or gall stones.
4. History of unexplained syncope, symptomatic hypotension, or hypoglycemia.
5. Family history of long QTc syndrome.
6. 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, hepatitis
C, or hepatitis E.
9. Hospital admission or major surgery within 6 months prior to screening.
10. History of alcohol or prescription drug abuse within 9 months prior to screening.
11. Positive test result for alcohol or drugs of abuse (i.e., UDS) at screening or
Admission.
12. Use of any prohibited medication(s) and/or substance(s), including:
1. use of any drugs known to induce or inhibit drug metabolism within 30 days prior
to Day 1;
2. receipt of another investigational medication (EXCEPT biological compound) within
30 days or receipt of biological compound within 90 days (or 5 half lives,
whichever is longer) prior to Day 1;
3. participation in an investigational device study within 30 days prior to Day 1.
4. routine consumption of the following within 14 days prior to Day 1:
i. Prescription medication (except hormonal contraception for WOCBP), OTC medication,
traditional Chinese medicine, or herbal medicine (within 14 days or 5 half lives,
whichever is longer); ii. Vitamin, mineral, and other dietary supplements; iii.
Grapefruit and grapefruit juice; e. donation of the following within the below
specified timeframe prior to Day 1: i. bone marrow or peripheral stem cells within 90
days; ii. blood within 60 days; iii. plasma within 30 days. f. Any of the following
activities within 72 hours prior to Day 1: i. strenuous exercise; ii. alcohol
consumption; iii. consumption of caffeine-containing substances.
13. Loss of >500 mL blood (for any reason) within 90 days prior to Day 1.
14. For 50 mg cohort only: inability to completely consume a standardized high fat
breakfast within 30 minutes.
15. Per investigator discretion, any other reason that would render a subject
inappropriate for study participation.
|
