| Eligibility |
Inclusion Criteria:
1. Healthy males or females aged 18 to 55 years, inclusive.
2. A male subject is eligible to participate if he does not have a female partner who is
pregnant or who intends to become pregnant during the study. Male subjects must agree
to use contraception starting at Screening, during the treatment period, and for at
least 100 days after the last dose of study drug, and refrain from donating sperm
during this period.
3. Female subjects of childbearing potential must agree to use contraception starting at
Screening, during the treatment period, and for at least 4 weeks after the last dose
of study drug.
4. Body mass index (BMI) = 18 kg/m2 and = 30 kg/m2.
5. Willing and able to give written informed consent and to comply with the requirements
of the study for its duration.
Exclusion Criteria:
1. As determined by the Investigator, any known pre existing medical or psychiatric
condition that could interfere with the subject's ability to provide informed consent
or participate in study conduct, or that may confound study findings including, but
not limited to a history of clinically significant gastrointestinal, hematologic,
renal, hepatic, bronchopulmonary, neurological, psychiatric, or cardiovascular
disease, including
1. History of Gilbert's Syndrome
2. History of depression
3. History of any allergy that, in the opinion of the Investigator, contraindicates
participation in the trial
2. Positive pregnancy test at Screening or Check-in.
3. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding
volume drawn at Screening) of 50 mL to 499 mL of blood within 30 days or more than 499
mL within 56 days prior to starting study drug.
4. Participation in an investigational drug, vaccine, or device study within 30 days
before study drug administration or 90 days for a biologic study.
5. Clinically significant ECG abnormalities.
6. Abnormal blood pressure, either low (defined as < 90 mmHg systolic and/or < 50 mmHg
diastolic) or high (defined as > 140 mmHg systolic and/or > 90 mmHg diastolic) at
Screening or prior to starting study drug.
7. Clinically significant abnormalities in laboratory test results, as determined by the
Investigator, (including hepatic and renal panels, complete blood count, coagulation,
chemistry panel, and urinalysis) at Screening or Check-in.
1. Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human
immunodeficiency virus (HIV).
2. Estimated glomerular filtration rate < 90 mL/min/1.73 m2 at Screening, calculated
using the Modification of Diet in Renal Disease (MDRD) formula.
3. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) values greater
than upper limit of normal (ULN).
4. Positive urine test for drugs of abuse at Screening or Check-in.
5. Positive alcohol test (breath, saliva, or urine) at Screening or Check-in.
6. Positive pregnancy test at Screening or Check-in.
8. Use of prescription or nonprescription drugs, (with exception of contraceptive and
acetaminophen allowance), including high dose vitamins, dietary supplements (including
St. John's Wort) within 14 days or 5 half lives of the prescription or nonprescription
drug (whichever was longer) prior to the first dose of study drug, through to the
final follow-up visit.
9. Consumption of grapefruit or Seville oranges or their juices within the 7 days prior
to dosing until collection of the final PK sample.
10. Use of medications associated with QT prolongation within 30 days prior to dosing and
during the study.
11. Subjects unable to abstain from alcohol for 72 hours prior to the start of dosing
through collection of the final PK sample.
12. Subjects with a clinical history of or current alcohol abuse defined as an average
weekly intake of more than 21 units for males or 15 units for females (1 unit = 340 mL
beer, 115 mL wine, or 43 mL spirits).
13. Subjects with a clinical history of or current illicit drug use which, in the opinion
of the Investigator, would interfere with the subject's ability to complete the study.
14. Subjects unable to abstain from caffeine, xanthine, or strenuous exercise for 72 hours
prior to dosing.
15. Subjects who have smoked or used tobacco- or nicotine containing products within 3
months prior to the Screening visit and who are unwilling to refrain from smoking,
tobacco use, or use of nicotine products for the entire duration of the study.
16. Employed as site personnel directly involved with this study
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