Fungal InfectionPhase 4NCT04035187

Itraconazole Oral Absorption

A Phase 4 study testing fast itraconazole tablet, medium itraconazole tablet and slow itraconazole tablet in people with Fungal Infection, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Fungal Infection
What is being tested?: fast itraconazole tablet, medium itraconazole tablet and slow itraconazole tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 10 Feb 2020to 21 May 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: 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.

Conditions: Fungal Infection
Being tested: fast itraconazole tablet, medium itraconazole tablet, slow itraconazole tablet, oral itraconazole solution
Medical subject headings: Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fast itraconazole tabletDrug
Also called fast dissolving itraconazole tablet
100mg dose
medium itraconazole tabletDrug
Also called medium dissolving itraconazole tablet
100mg dose
slow itraconazole tabletDrug
Also called slow dissolving itraconazole tablet
100mg dose
oral itraconazole solutionDrug
Also called commercial oral itraconazole solution
100mg dose

Study groups in NCT04035187
Study group	Role	What they receive
Sequence A (fast, medium, oral solution, then slow)	Experimental	Participants first receive fast tablet, then medium tablet, then oral solution, and then slow tablet. Washout period is (at least) one week. Receives: Drug: fast itraconazole tablet; Drug: medium itraconazole tablet; Drug: slow itraconazole tablet; Drug: oral itraconazole solution
Sequence B (medium, slow, fast, then oral solution)	Experimental	Participants first receive medium tablet, then slow tablet, then fast tablet, and then oral solution. Washout period is (at least) one week. Receives: Drug: fast itraconazole tablet; Drug: medium itraconazole tablet; Drug: slow itraconazole tablet; Drug: oral itraconazole solution
Sequence C (slow, oral solution, medium, then fast)	Experimental	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. Receives: Drug: fast itraconazole tablet; Drug: medium itraconazole tablet; Drug: slow itraconazole tablet; Drug: oral itraconazole solution
Sequence D (oral solution, fast, slow, then medium)	Experimental	Participants first receive oral solution, fast tablet, then slow tablet, and then medium tablet. Washout period is (at least) one week. Receives: Drug: fast itraconazole tablet; Drug: medium itraconazole tablet; Drug: slow itraconazole tablet; Drug: oral itraconazole solution

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC
area under the curve from 0-72hr
Measured: 0-72hr

Secondary outcomes (1)

Cmax
maximum concentration during the time interval
Measured: 0-72hr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 202021 May 2022

First posted29 Jul 2019
Study start10 Feb 2020
Primary completion21 May 2022
Study completion21 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Fungal InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04035187
Sponsor's protocol ID: HP-00084585
Status last verified: Sep 2023
First submitted: 24 Jul 2019
Last updated: 5 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingPhase 2
Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy
Invasive Mould Infection
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin Resistance in Staphylococcus Aureus (MRSA)
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial

All Fungal Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prediction of Itraconazole Oral Absorption From In Vitro Dissolution
ClinicalTrials.gov ID: NCT04035187
Acronym / sponsor ID: HP-00084585
Conditions: Fungal Infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Study start: 10 Feb 2020 (actual)
Primary completion: 21 May 2022 (actual)
Study completion: 21 May 2022 (actual)
First posted: 29 Jul 2019 (actual)
Results: Posted 5 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Sequence A (fast, medium, oral solution, then slow)	Experimental	Drug: fast itraconazole tablet, Drug: medium itraconazole tablet, Drug: slow itraconazole tablet, Drug: oral itraconazole solutionParticipants first receive fast tablet, then medium tablet, then oral solution, and then slow tablet. Washout period is (at least) one week.
Sequence B (medium, slow, fast, then oral solution)	Experimental	Drug: fast itraconazole tablet, Drug: medium itraconazole tablet, Drug: slow itraconazole tablet, Drug: oral itraconazole solutionParticipants first receive medium tablet, then slow tablet, then fast tablet, and then oral solution. Washout period is (at least) one week.
Sequence C (slow, oral solution, medium, then fast)	Experimental	Drug: fast itraconazole tablet, Drug: medium itraconazole tablet, Drug: slow itraconazole tablet, Drug: oral itraconazole solution3, 4, 2, 1 Participants first receive slow tablet, then oral solution, then medium tablet, then fast tablet. Washout period is (at least) one week.
Sequence D (oral solution, fast, slow, then medium)	Experimental	Drug: fast itraconazole tablet, Drug: medium itraconazole tablet, Drug: slow itraconazole tablet, Drug: oral itraconazole solutionParticipants first receive oral solution, fast tablet, then slow tablet, and then medium tablet. Washout period is (at least) one week.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fast itraconazole tabletAlso: fast dissolving itraconazole tablet100mg dose	Drug	Sequence A (fast, medium, oral solution, then slow), Sequence B (medium, slow, fast, then oral solution), Sequence C (slow, oral solution, medium, then fast), Sequence D (oral solution, fast, slow, then medium)
medium itraconazole tabletAlso: medium dissolving itraconazole tablet100mg dose	Drug	Sequence A (fast, medium, oral solution, then slow), Sequence B (medium, slow, fast, then oral solution), Sequence C (slow, oral solution, medium, then fast), Sequence D (oral solution, fast, slow, then medium)
slow itraconazole tabletAlso: slow dissolving itraconazole tablet100mg dose	Drug	Sequence A (fast, medium, oral solution, then slow), Sequence B (medium, slow, fast, then oral solution), Sequence C (slow, oral solution, medium, then fast), Sequence D (oral solution, fast, slow, then medium)
oral itraconazole solutionAlso: commercial oral itraconazole solution100mg dose	Drug	Sequence A (fast, medium, oral solution, then slow), Sequence B (medium, slow, fast, then oral solution), Sequence C (slow, oral solution, medium, then fast), Sequence D (oral solution, fast, slow, then medium)

Primary outcome

AUC
Time frame: 0-72hr
area under the curve from 0-72hr

1 secondary outcome

Cmax
Time frame: 0-72hr

Results and safety

Results posted to the registry on 5 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence A (Fast, Medium, Oral Solution, Then Slow)	4	2
Sequence B (Medium, Slow, Fast, Then Oral Solution)	4	2
Sequence C (Slow, Oral Solution, Medium, Then Fast)	4	4
Sequence D (Oral Solution, Fast, Slow, Then Medium)	5	4

Primary outcome: AUC

Time frame: 0-72hr. Mean (Standard Error). Unit: ng*hr/mL

Measure	Fast Tablet n = 12	Medium Tablet n = 12	Slow Tablet n = 12	Oral Solution n = 12
Value	1624.8 (146.1)	1365.5 (184)	1282.2 (220.3)	1848.7 (139.7)

Population analysed: Seventeen participants were randomized in this cross-over study to receive all 4 itraconazole products at least one week apart. Twelve participants completed all 4 interventions. Analysis was only done of data from participants who completed all four interventions (n=12).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fast Tablet	0 of 14 (0%)	3 of 14 (21.4%)	0 of 14
Medium Tablet	0 of 14 (0%)	1 of 14 (7.1%)	0 of 14
Slow Tablet	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Oral Solution	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Fungal Infection

RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingPhase 2
Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy
Invasive Mould Infection
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin Resistance in Staphylococcus Aureus (MRSA)
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
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Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC (time frame: 0-72hr). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04035187.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.