| Eligibility |
Inclusion Criteria:
1. Healthy, adult, male or female (non-lactating and not of childbearing potential)
subjects age 19 to 55 inclusive.
2. Females must have undergone one of the following sterilization procedures at least 6
months prior to the first dosing:
1. hysteroscopic sterilization
2. bilateral tubal ligation or bilateral salpingectomy
3. hysterectomy
4. bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year
prior to the first dosing and follicle stimulating hormone (FSH) serum levels
consistent with postmenopausal status.
3. Good general health, with no significant medical history. Subjects must have no
clinically significant abnormalities on physical examination at screening, and/or
before administration of the initial dose of study drug.
4. Body weight = 50 kg at the screening visit.
5. Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
6. Has laboratory values (clinical chemistry and hematology) within the normal reference
range. Deviations from this range may be acceptable if they are considered 'not
clinically significant' (NCS) by the PI.
7. Males who have not been vasectomized participating in the study must agree to use at
least 2 approved methods of contraception (ie double-barrier or barrier plus
hormonal), or abstain from sexual intercourse, from Day -2 to 4 weeks after dosing (or
last dose Parts B)
8. Is a non-smoker and must not have used any nicotine products within three months prior
to screening.
9. Able and willing to attend the necessary visits to the study center.
Exclusion Criteria:
1. Blood donation or recipient of blood transfusion in previous 12 weeks.
2. History of clinically significant endocrine, neurological, gastrointestinal,
cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
genitourinary abnormalities or diseases. Cardiovascular history should include
assessment of risk factors for Torsades de Pointes Risk (e.g., heart failure,
pulmonary edema, cardiomyopathy, hypokalemia, hypomagnesemia, or hypocalcemia, or
family history of Long QT Syndrome, syncope or sudden death).
3. History of neoplastic disease (with the exception of adequately treated
non-melanomatous skin carcinoma).
4. Mentally or legally incapacitated (e.g., has significant emotional problems at the
time of Screening Visit or expected during the conduct of the study, or has a history
of a clinically significant psychiatric disorder within the last 5 years).
5. Fever (body temperature >38C) or symptomatic viral/bacterial infection or use of
antibi-otics within 2 weeks prior to Screening.
6. Supine resting blood pressure (BP) >140/90 mmHg or heart rate (HR) outside the range
40 to 100 beats per minute at Screening and at Day -1.
7. Clinically significant abnormality on ECG performed at the Screening Visit or prior to
administration of the initial dose of study drug. (Sick sinus syndrome, second or
third degree atrioventricular block, myocardial infarction, symptomatic or significant
cardiac arrhythmia, prolonged QTcF interval, or bundle branch block.
8. Out of range (on repeat) testing for coagulation tests including fibrinogen.
9. Clinically significant laboratory abnormalities including: Impaired renal function
(estimated creatinine clearance (CrCl) of <80 mL/minute based on CrCl = (140-age
[years])(body weight [kg])/(72)(serum creatinine [mg/dL])).
10. Positive test for hepatitis C antibody, hepatitis B surface antigen, or human
immunodefi-ciency virus (HIV) antibody at Screening.
11. Participants with a positive toxicology screening panel (urine test including
qualitative identi¬fication of barbiturates, tetrahydrocannabinol, amphetamines,
benzodiazepines, opiates, cocaine, cotinine and ethanol).
12. Participants with a history of substance abuse or dependency or history of
recreational IV drug use (by self-declaration).
13. Participant has a suspected history of alcohol abuse in the 6 months prior to
screening.
14. Use of NSAIDs, aspirin or aspirin-containing medications (and other medications
affecting platelet function [for example cilostazol, clopidogrel, ticagrelor,
prasugrel, dipyridamole]) in the 14 days prior to dosing with study medication.
15. Unable to refrain from or anticipates the use of any medications, including
prescription and non-prescription drugs and herbal remedies (such as St. John's Wort
[Hypericum perforatum]), beginning 14 days (or 5 half-lives, whichever is longer)
before administration of the initial dose of study drug and continuing throughout the
study until the final study visit. There may be certain medications that are permitted
at the discretion of the Investigator and Sponsor (including
paracetamol/acetaminophen, medications for the treatment of AEs following
administration of study drug).
16. Subjects who are unlikely to comply with the study protocol or, in the opinion of the
investigator, would not be a suitable candidate for participation in the study.
17. Have participated in any other investigational drug trial within 30 days of dosing in
the present study.
|
