Healthy | Non-smoker
Item
are a healthy, non-smoking male or female.
boolean
C3898900 (UMLS CUI [1])
C0337672 (UMLS CUI [2])
Age
Item
are 18 to 55 years old, inclusive.
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
have a body weight of > or equal to 110 pounds.
boolean
C0005910 (UMLS CUI [1])
Gender Childbearing Potential Lacking | Gender Pregnancy test negative
Item
are a female who is unable to have any more children and have a negative pregnancy test.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Informed Consent
Item
are willing and able to provide written informed consent before the start of any study-related procedures.
boolean
C0021430 (UMLS CUI [1])
Comprehension Study Protocol | Protocol Compliance
Item
are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Tobacco use
Item
smoke or use any tobacco products.
boolean
C0543414 (UMLS CUI [1])
Ketoconazole allergy | Allergic Reaction Investigational New Drugs
Item
have a known allergic reaction to ketoconazole or study drug.
boolean
C0571275 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Alcohol consumption Regular Alcoholic drink Weekly | Gender
Item
have a history of regular alcohol consumption greater than 7 drinks per week for females or greater than 14 drinks per week for males.
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0001967 (UMLS CUI [1,3])
C0332174 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2])
Blood-drug tests Positive | Blood alcohol test positive | Smoking Test Positive
Item
have a positive drug or alcohol or smoking test at screening or check-in to the clinic.
boolean
C0868677 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0948726 (UMLS CUI [2])
C0037369 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs
Item
have participated in another clinical trial within 30 days prior to screening in which you have received an investigational drug.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Blood Donation pint
Item
have donated a pint of blood within 56 days before the first dose of study drug.
boolean
C0005794 (UMLS CUI [1,1])
C0560012 (UMLS CUI [1,2])
Medical condition Stomach | Medical condition Stomach Suspected | Operation on stomach
Item
have any known or suspected stomach condition (or stomach surgery within the 6 months prior to dosing).
boolean
C3843040 (UMLS CUI [1,1])
C0038351 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0038351 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
C0192398 (UMLS CUI [3])
Liver test abnormal
Item
have abnormal liver test results.
boolean
C0745768 (UMLS CUI [1])
Liver Cirrhosis
Item
have a documented history or diagnosis of cirrhosis.
boolean
C0023890 (UMLS CUI [1])
Hepatitis C positive | Hepatitis B positive | HIV Seropositivity
Item
have positive results for hepatitis c or b, or hiv at screening.
boolean
C1112419 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Abnormal blood pressure
Item
have blood pressure outside of the normal range.
boolean
C0005826 (UMLS CUI [1])
Gender Sexual Abstinence Unwilling | Gender Contraceptive methods Unwilling
Item
are a male subject who is unwilling to either abstain from sexual activity or unwilling to use birth control during the course of the study.
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Non-Prescription Drugs Use of | Vitamins | Herbal supplement | Dietary Supplements | ST. JOHN'S WORT EXTRACT
Item
are using non-prescription drugs, vitamins, herbal or dietary supplements (including st john's wort) within 7 days before the first dose of study medication,
boolean
C0013231 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0042890 (UMLS CUI [2])
C1504473 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0813171 (UMLS CUI [5])
Abnormality Study Subject Participation Status Inappropriate | Physical Examination | Laboratory examination
Item
have any abnormality identified on the screening physical or laboratory examination that the study physician feels would make it inappropriate for you to participate in the study.
boolean
C1704258 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2])
C0260877 (UMLS CUI [3])