Itraconazole Oral Absorption

September 11, 2023 updated by: James E Polli, University of Maryland, Baltimore

Prediction of Itraconazole Oral Absorption From In Vitro Dissolution

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence A (fast, medium, oral solution, then slow)
Participants first receive fast tablet, then medium tablet, then oral solution, and then slow tablet. Washout period is (at least) one week.
Drug: fast itraconazole tablet
100mg dose
Other Names:
  • fast dissolving itraconazole tablet
Drug: medium itraconazole tablet
100mg dose
Other Names:
  • medium dissolving itraconazole tablet
Drug: slow itraconazole tablet
100mg dose
Other Names:
  • slow dissolving itraconazole tablet
Drug: oral itraconazole solution
100mg dose
Other Names:
  • commercial oral itraconazole solution
Experimental: Sequence B (medium, slow, fast, then oral solution)
Participants first receive medium tablet, then slow tablet, then fast tablet, and then oral solution. Washout period is (at least) one week.
Drug: fast itraconazole tablet
100mg dose
Other Names:
  • fast dissolving itraconazole tablet
Drug: medium itraconazole tablet
100mg dose
Other Names:
  • medium dissolving itraconazole tablet
Drug: slow itraconazole tablet
100mg dose
Other Names:
  • slow dissolving itraconazole tablet
Drug: oral itraconazole solution
100mg dose
Other Names:
  • commercial oral itraconazole solution
Experimental: Sequence C (slow, oral solution, medium, then fast)
3, 4, 2, 1 Participants first receive slow tablet, then oral solution, then medium tablet, then fast tablet. Washout period is (at least) one week.
Drug: fast itraconazole tablet
100mg dose
Other Names:
  • fast dissolving itraconazole tablet
Drug: medium itraconazole tablet
100mg dose
Other Names:
  • medium dissolving itraconazole tablet
Drug: slow itraconazole tablet
100mg dose
Other Names:
  • slow dissolving itraconazole tablet
Drug: oral itraconazole solution
100mg dose
Other Names:
  • commercial oral itraconazole solution
Experimental: Sequence D (oral solution, fast, slow, then medium)
Participants first receive oral solution, fast tablet, then slow tablet, and then medium tablet. Washout period is (at least) one week.
Drug: fast itraconazole tablet
100mg dose
Other Names:
  • fast dissolving itraconazole tablet
Drug: medium itraconazole tablet
100mg dose
Other Names:
  • medium dissolving itraconazole tablet
Drug: slow itraconazole tablet
100mg dose
Other Names:
  • slow dissolving itraconazole tablet
Drug: oral itraconazole solution
100mg dose
Other Names:
  • commercial oral itraconazole solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: 0-72hr
area under the curve from 0-72hr
0-72hr

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 0-72hr
maximum concentration during the time interval
0-72hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HP-00084585

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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