Itraconazole Oral Absorption
Condition: Fungal Infection
MeSH terms: Mycoses
Intervention: fast itraconazole tablet; medium itraconazole tablet; slow itraconazole tablet; oral itraconazole solution
Intervention description: 100mg dose; 100mg dose; 100mg dose; 100mg dose
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole; Pharmaceutical Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      For tablets to be absorbed, the drug must dissolve after being swallowed. Drugs with low
      solubility sometimes require the inert ingredients in tablets to help the drug dissolve after
      being swallowed. This study uses itraconazole as an example drug with low solubility.
      Itraconazole tablets with different inert ingredients and manufacturing will be administered
      to healthy volunteers to see if the different inert ingredients and manufacturing impact drug
      absorption.
    

Eligibility criteria:

        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.