Eligibility Details:
Inclusion Criteria:
- Subject is healthy, as determined by screening evaluation that is not greater than 30
days before the first drug study visit
- Subject is male or female between 18 and 65 years of age inclusive.
- Subject is an acceptable candidate for venipuncture.
- Subject is willing to stop all non-routine OTC medications, as well as vitamins,
dietary supplements, and herbals, for 24 hours prior to study drug administration and
during pharmacokinetic study visits.
- Subject is willing, for each of the four drug study periods, to stop consuming
grapefruit, grapefruit products, star fruit, star fruit products, Seville oranges, and
St. John's wort from 72-hour before study drug administration until the period's last
blood sample
- Subject is willing to not smoke (or use e-cigarettes) during study visits.
Exclusion Criteria:
- Subject has a significant medical disease (including cardiovascular, pulmonary,
hematologic, endocrine, immunologic, neurologic, gastrointestinal or psychiatric).
- Subject shows evidence of congestive heart failure or history of congestive heart
failure.
- Subject exhibits electrocardiogram (12 lead) with clinically significant abnormalities
(e.g. QTcF >450 msec).
- Subject has a history of alcohol or drug abuse, which in the opinion of the
investigator, could jeopardize the subject's health or would compromise the subject's
ability to participate in this trial.
- Subject is pregnant, breast feeding, or trying to become pregnant.
- Female subject of childbearing potential is unwilling or unable to use a medically
acceptable method of contraception throughout the entire study period and for one week
after the study is completed. Medically acceptable methods of contraception that may
be used by the subject and/or her partner are: oral birth control pill, condom with
spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical
sterilization of patient or their partner(s), abstinence, or hormonal-based patches,
ring, injections, and implants.
- Subject routinely uses (i.e. daily or weekly) prescription medication except hormonal
birth control medication, routinely uses (i.e. daily or weekly) OTC medication, or
routinely uses (i.e. daily or weekly) St. John's Wort. OTC medications do not include
vitamins, dietary supplements, or herbals.
- Subject routinely uses (i.e. daily or weekly) acid blockers, antacids, anti-diarrhea,
stimulants, appetite suppressants, or anti-nausea medication or other drugs that
modulate GI functio
- Subject is currently taking itraconazole or medication known to interact with
itraconazole.
- Subject is allergic to itraconazole.
- Subject has liver impairment as assessed by alanine aminotransferase (ALT), aspartate
aminotransferase (AST), or total bilirubin levels greater than the upper limit of
normal (ULN).
- Subject has renal impairment as assessed by creatinine clearance lower than
50mL/min/1.73m2, using the CKD-EPI formula.
- Subject is not willing or able to be adherent to study protocol (e.g. study visits).
- Subject has a condition in which in the opinion of the PI or medical physician would
increase risk to the subject or interfere with the integrity of the study.
- Subject has received an investigational product within 30 days prior to study drug
administration, plans to receive an investigational product during their study
participation period, or plans to donate blood to any other clinical trial during
their study participation period.
- Subject has provided plasma donation within 1 month of screening or any blood
donation/loss more than 500 mL within 8 weeks prior to study drug administration.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
