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Itraconazole Oral Absorption

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ClinicalTrials.gov Identifier: NCT04035187
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
James E Polli, University of Maryland, College Park

Brief 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.

Condition or disease Intervention/treatment Phase
Fungal Infection Drug: fast itraconazole tablet Drug: medium itraconazole tablet Drug: slow itraconazole tablet Drug: oral itraconazole solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Prediction of Itraconazole Oral Absorption From In Vitro Dissolution
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: fast dissolving itraconazole tablet

Drug: medium itraconazole tablet
100mg dose
Other Name: medium dissolving itraconazole tablet

Drug: slow itraconazole tablet
100mg dose
Other Name: slow dissolving itraconazole tablet

Drug: oral itraconazole solution
100mg dose
Other Name: 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 Name: fast dissolving itraconazole tablet

Drug: medium itraconazole tablet
100mg dose
Other Name: medium dissolving itraconazole tablet

Drug: slow itraconazole tablet
100mg dose
Other Name: slow dissolving itraconazole tablet

Drug: oral itraconazole solution
100mg dose
Other Name: 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 Name: fast dissolving itraconazole tablet

Drug: medium itraconazole tablet
100mg dose
Other Name: medium dissolving itraconazole tablet

Drug: slow itraconazole tablet
100mg dose
Other Name: slow dissolving itraconazole tablet

Drug: oral itraconazole solution
100mg dose
Other Name: 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 Name: fast dissolving itraconazole tablet

Drug: medium itraconazole tablet
100mg dose
Other Name: medium dissolving itraconazole tablet

Drug: slow itraconazole tablet
100mg dose
Other Name: slow dissolving itraconazole tablet

Drug: oral itraconazole solution
100mg dose
Other Name: commercial oral itraconazole solution




Primary Outcome Measures :
  1. AUC [ Time Frame: 0-72hr ]
    area under the curve from 0-72hr

  2. Cmax [ Time Frame: 0-72hr ]
    maximum concentration during the time interval



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035187


Contacts
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Contact: James Polli 410-706-8292 jpolli@rx.umaryland.edu

Sponsors and Collaborators
University of Maryland, Baltimore
Food and Drug Administration (FDA)

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Responsible Party: James E Polli, Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT04035187     History of Changes
Other Study ID Numbers: HP-00084585
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: July 2019

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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
Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Mycoses
Pharmaceutical Solutions
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors