Eligibility Details:
Inclusion Criteria:
- Healthy on the basis of medical history, physical examination, vital signs,
electrocardiogram (ECG), and laboratory test results, including serum chemistry, blood
coagulation, hematology, and urinalysis performed at screening. If there are
abnormalities, the investigator may decide that the abnormalities or deviations from
normal are not clinically significant. This determination must be recorded in the
participant's source documents and initialed by the investigator
- If a woman, except for postmenopausal women, must have a negative highly sensitive
serum (beta human chorionic gonadotropin [beta-hCG]) at screening and urine (beta-hCG)
pregnancy test on Day -1 of treatment period
- Contraceptive use by men or women should be consistent with local regulations
regarding the use of contraceptive methods for participant participating in clinical
studies
- Body mass index (BMI; weight kilogram per meter square [kg/m^2]) between 18 and 30
kg/m^2 (inclusive), and body weight not less than 50 kilogram (kg)
- After being supine for 10 minutes, systolic blood pressure between 90 and 140
millimeter of Mercury (mmHg), inclusive; and no higher than 90 mmHg diastolic blood
pressure
Exclusion Criteria:
- If a woman, pregnant, breast-feeding or planning to become pregnant during the study
- History of any known illness that, in the opinion of the investigator, might confound
the results of the study or pose an additional risk in administering study drug to the
participant or that could prevent, limit or confound the protocol specified
assessments. This may include but is not limited to any known bleeding or clotting
disorder, a history of arterial or venous thrombosis, liver or renal dysfunction,
significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
hematologic, rheumatologic, psychiatric, neoplastic abnormalities, metabolic
disturbances, or poor venous access
- Participants with current hepatitis B infection (confirmed by hepatitis B surface
antigen [HBsAg]), or hepatitis C infection (confirmed by hepatitis C virus [HCV]
antibody), or human immunodeficiency virus type-1 (HIV-1) or HIV-2 infection at study
screening
- History of, or a reason to believe a participant has a history of, drug or alcohol
abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition)
(DSM V) criteria within the past 1 year, which in the investigator's opinion would
compromise participant safety and/or compliance with the study procedures
- History of any clinically significant drug or food allergies (such as anaphylaxis or
hepatotoxicity) and known allergy to the study drugs or any of the excipients of the
formulation. History of allergy to or unwillingness to consume any component of the
high-fat breakfast menu to be provided in this study
- Clinically significant abnormal values for hematology, coagulation, clinical chemistry
or urinalysis at Screening or on Day -1 prior to the first dosing as determined by the
investigator or appropriate designee. Any of the following laboratory results outside
of the ranges specified below at screening or Day -1 prior to first dosing, confirmed
by repeat: Hemoglobin or hematocrit < lower limit of normal; Platelet count < lower
limit of normal; activated partial thromboplastin time (aPTT), or prothrombin time
(PT) greater than (>) 1.2 × upper limit of normal (ULN)
- Any of the following on 12-lead ECG and assessment of QT interval prior to study
treatment administration, confirmed by repeat at screening and Day -1 of treatment
period: Heart rate >100 beats per minute (bpm); PR >= 210 milli second (ms); QRS >=120
ms; QTcF >= 450 ms for male and >= 470 ms for female
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
