Entry criteria fulfilled
Item
Did the subject meet all the entry criteria?
boolean
C1550543 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Participant Healthy
Item
Is the participant healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests and cardiac monitoring?
boolean
C0681850 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0521095 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C3826004 (UMLS CUI [1,5])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C0150496 (UMLS CUI [5])
Age
Item
Is the participant between 18 and 65 years of age, inclusive?
boolean
C0001779 (UMLS CUI [1])
Weight and BMI
Item
Is the body weight > 50 kg (110 pounds) and body mass index (BMI) between 19 and 30?
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Informed Consent
Item
Is the participant capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form?
boolean
C2698977 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0009797 (UMLS CUI [2,2])
Clinically relevant abnormality
Item
Does the participant have any clinically relevant abnormality identified on the screening medical assessment, laboratory examination or ECG?
boolean
C0205210 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0582103 (UMLS CUI [1,4])
C0205210 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
C0260877 (UMLS CUI [2,4])
C0205210 (UMLS CUI [3,1])
C2347946 (UMLS CUI [3,2])
C1704258 (UMLS CUI [3,3])
C0013798 (UMLS CUI [3,4])
Asthma, Anaphylaxis, anaphylactoid reactions or severe allergic responses
Item
Does the participant have a history of asthma, anaphylaxis or anaphalactoid reactions, severe allergic responses?
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0002792 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0340865 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C1527304 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
Alcohol consumption
Item
Does the participant have a history of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men within 6 months of screening?
boolean
C0001948 (UMLS CUI [1])
Positive Drug or alcohol screen
Item
Does the subject have a positive pre-study urine drug/ urine alcohol screen?
boolean
C1527048 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C1527048 (UMLS CUI [2,1])
C0420032 (UMLS CUI [2,2])
C1446409 (UMLS CUI [2,3])
HIV, Hepatitis B or Hepatitis C positive
Item
Is the subject positive for HIV, Hepatitis B or Hepatitis C at screening?
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Medication or supplement use
Item
Does the subject use prescription (including hormone replacement) or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort)?
boolean
C0457083 (UMLS CUI [1,1])
C0304227 (UMLS CUI [1,2])
C0457083 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0042890 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
Exposure to new chemical entities
Item
Does the subject have exposure to more than four new chemical entities within 12 months prior to the first dosing day?
boolean
C0332157 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0220806 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,5])
C0439228 (UMLS CUI [1,6])
Received clinical trial medication recently
Item
Has the subject participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication?
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0205314 (UMLS CUI [2,3])
C0220806 (UMLS CUI [2,4])
C0332152 (UMLS CUI [2,5])
C0332185 (UMLS CUI [2,6])
Grapefruit juice consumption
Item
Did the subject consume grapefruit or grapefruit juice within 7 days prior to the first dose of study medication?
boolean
C0995150 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0452456 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Cholecystectomy or biliary tract disease
Item
Does the participant have a history of cholecystectomy or biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology?
boolean
C0262926 (UMLS CUI [1,1])
C0008320 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0005424 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0023895 (UMLS CUI [3,2])
C3163633 (UMLS CUI [3,3])
C0023901 (UMLS CUI [3,4])
Pregnant or nursing
Item
Is the subject pregnant or nursing?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive method
Item
Does the subject have a use of oral, injected and implanted hormonal methods of contraception (for female subjects)?
boolean
C0442027 (UMLS CUI [1,1])
C0458083 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C2986768 (UMLS CUI [2,1])
C0458083 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0021102 (UMLS CUI [3,1])
C0458083 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Excess blood donation
Item
Would participation in the study result in donation of blood in excess of 500 mL within a 56 day period?
boolean
C2348568 (UMLS CUI [1,1])
C0553700 (UMLS CUI [1,2])
C0442802 (UMLS CUI [1,3])
Sensitivity to study medication
Item
Does the participant have a history of sensitivity to any of the study medications (including ketoconazole for Part B only), or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation?
boolean
C0020517 (UMLS CUI [1,1])
C4284232 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0522473 (UMLS CUI [1,4])
C2348568 (UMLS CUI [1,5])
C0020517 (UMLS CUI [2,1])
C0184498 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0522473 (UMLS CUI [2,4])
C2348568 (UMLS CUI [2,5])
C0020517 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0522473 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
Heparin sensitivity or HIT
Item
Does the participant have a history of sensitivity to heparin or heparin-induced thrombocytopenia (if heparin is to be used for flushing a cannula)?
boolean
C0262926 (UMLS CUI [1,1])
C0272285 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
CYP3A4 inducers
Item
Does the subject have a use of other CYP 3A4 inhibitors or inducers within 14 days prior to dosing of study medication (Part B only)?
boolean
C0457083 (UMLS CUI [1,1])
C3830625 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0457083 (UMLS CUI [2,1])
C3830624 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])