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Study to Evaluate Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers

Primary Purpose

Achlorhydria

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Itraconazole 200 mg
Esomeprazole 40 mg
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achlorhydria

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adult aged ≥ 19 years and ≤ 50 years at the time of screening
  • Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 19.0 kg/m2 and ≤ 30.0 kg/m2 at the time of screening
  • A subject without any congenital or chronic disease, and has no medical examination result as pathological symptoms or signs
  • A subject who listened to sufficient explanation and fully understood this study, and voluntarily decided to participate and agreed in writing to comply with the precautions
  • A subject determined eligible for this study by investigator based physical examination, clinical laboratory tests, interview, etc.

Exclusion Criteria:

  • A subject with clinically significant hepatobiliary (severe hepatic impairment, etc.), renal (severe renal impairment, etc.), neurologic, immunologic, respiratory, gastrointestinal, endocrine, blood•oncology, cardiovascular (heart failure, Torsades de pointes, etc.), urinary, or, psychical diseases (except for simple dental past history such as tartar, impacted tooth, or wisdom tooth) or a history
  • A subject who has hypersensitivity to the investigational products, drugs containing the same class, or other drugs (penicillin and antibiotics, etc.), or a history of clinically significant hypersensitivity
  • A subject with a history of gastrointestinal disorders (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or surgery (except for simple appendectomy and herniotomy) that may affect the safety and pharmacokinetics of the investigational products
  • A subject with the following results in the screening test:

    1. Blood AST (GOT), ALT (GPT): > Normal range upper × 1.5
    2. QTc interval: > 450 ms
    3. Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test)
  • A subject with systolic blood pressure < 80 mmHg or > 160 mmHg, or diastolic blood pressure < 50 mmHg or > 100 mmHg when vital signs are measured in sitting position after resting for at least 3 minutes
  • A subject with a history of drug abuse
  • A subject who administered any prescription drugs or herbal medicine within 2 weeks prior to the expected date of the first dose, or any over-the-counter drug (OTC drug, health functional food or vitamin within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise decided eligible by the investigator), or is expected to administer it
  • A subject who administered drugs that induce (such as barbitals) or inhibit (such as clarithromycin) the drug metabolizing enzymes within 1 month prior to the expected date of the first dose
  • A subject who participated in other clinical trial or bioequivalence study within 6 months prior to the expected date of the first dose
  • A subject who donated whole blood within 2 months or the component blood within 1 month prior to the expected date of the first dose, or received blood transfusion within 1 month prior to the expected date of the first dose
  • A subject with persistent alcohol intake (> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to abstain from drinking from 3 days before the expected date of the first dose until the last discharge
  • A subject with inability to refrain from grapefruit-containing food from 3 days before the expected date of the first dose until the last discharge
  • A subject with excessive caffeine intake (> 5 units/day), or inability to refrain from caffeine or caffeine-containing food from 3 days before the expected date of the first dose until the last discharge
  • A subject with inability to use a medically acceptable double contraception or contraception throughout the study and for at least 4 weeks after the last dose, and with inability to agree to donate sperm until the period

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Itraconazole 200 mg under fasted condition

Itraconazole 200 mg under fed condition

Esomeprazole 40 mg + Itraconazole 200 mg under fasted condition

Arm Description

A single oral administration of itraconazole 200 mg under fasted condition

A single oral administration of itraconazole 200 mg under fed condition

Oral administration of esomeprazole 40 mg once daily for 6 days and then a single oral administration of itraconazole 200 mg under fasted condition

Outcomes

Primary Outcome Measures

Cmax of itraconazole
Pharmacokinetic parameters of itraconazole
AUClast of itraconazole
Pharmacokinetic parameters of itraconazole
AUCinf of itraconazole
Pharmacokinetic parameters of itraconazole
Tmax of itraconazole
Pharmacokinetic parameters of itraconazole
t1/2 of itraconazole
Pharmacokinetic parameters of itraconazole
CL/F of itraconazole
Pharmacokinetic parameters of itraconazole
Vd/F of itraconazole
Pharmacokinetic parameters of itraconazole
Cmax of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
AUClast of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
AUCinf of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Tmax of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
t1/2 of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
metabolic ratio of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole

Secondary Outcome Measures

Full Information

First Posted
June 20, 2021
Last Updated
September 23, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04942652
Brief Title
Study to Evaluate Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers
Official Title
An Open-label, Three-period, One-sequence Crossover Clinical Trial to Evaluate the Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
August 6, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the effects of food or proton pump inhibitor on the pharmacokinetics of itraconazole in healthy volunteers.
Detailed Description
Evaluation criteria Pharmacokinetic assessment with plasma concentrations of itraconazole and hydroxy-itraconazole Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, and laboratory tests

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achlorhydria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Itraconazole 200 mg under fasted condition
Arm Type
Experimental
Arm Description
A single oral administration of itraconazole 200 mg under fasted condition
Arm Title
Itraconazole 200 mg under fed condition
Arm Type
Experimental
Arm Description
A single oral administration of itraconazole 200 mg under fed condition
Arm Title
Esomeprazole 40 mg + Itraconazole 200 mg under fasted condition
Arm Type
Experimental
Arm Description
Oral administration of esomeprazole 40 mg once daily for 6 days and then a single oral administration of itraconazole 200 mg under fasted condition
Intervention Type
Drug
Intervention Name(s)
Itraconazole 200 mg
Other Intervention Name(s)
Sporanox capsule
Intervention Description
Itraconazole 100 mg capsule x 2
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 40 mg
Other Intervention Name(s)
Nexium
Intervention Description
Esomeprazole 40 mg tablet x 1
Primary Outcome Measure Information:
Title
Cmax of itraconazole
Description
Pharmacokinetic parameters of itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
AUClast of itraconazole
Description
Pharmacokinetic parameters of itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
AUCinf of itraconazole
Description
Pharmacokinetic parameters of itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
Tmax of itraconazole
Description
Pharmacokinetic parameters of itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
t1/2 of itraconazole
Description
Pharmacokinetic parameters of itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
CL/F of itraconazole
Description
Pharmacokinetic parameters of itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
Vd/F of itraconazole
Description
Pharmacokinetic parameters of itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
Cmax of hydroxy-itraconazole
Description
Pharmacokinetic parameters of hydroxy-itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
AUClast of hydroxy-itraconazole
Description
Pharmacokinetic parameters of hydroxy-itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
AUCinf of hydroxy-itraconazole
Description
Pharmacokinetic parameters of hydroxy-itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
Tmax of hydroxy-itraconazole
Description
Pharmacokinetic parameters of hydroxy-itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
t1/2 of hydroxy-itraconazole
Description
Pharmacokinetic parameters of hydroxy-itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Title
metabolic ratio of hydroxy-itraconazole
Description
Pharmacokinetic parameters of hydroxy-itraconazole
Time Frame
Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult aged ≥ 19 years and ≤ 50 years at the time of screening Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 19.0 kg/m2 and ≤ 30.0 kg/m2 at the time of screening A subject without any congenital or chronic disease, and has no medical examination result as pathological symptoms or signs A subject who listened to sufficient explanation and fully understood this study, and voluntarily decided to participate and agreed in writing to comply with the precautions A subject determined eligible for this study by investigator based physical examination, clinical laboratory tests, interview, etc. Exclusion Criteria: A subject with clinically significant hepatobiliary (severe hepatic impairment, etc.), renal (severe renal impairment, etc.), neurologic, immunologic, respiratory, gastrointestinal, endocrine, blood•oncology, cardiovascular (heart failure, Torsades de pointes, etc.), urinary, or, psychical diseases (except for simple dental past history such as tartar, impacted tooth, or wisdom tooth) or a history A subject who has hypersensitivity to the investigational products, drugs containing the same class, or other drugs (penicillin and antibiotics, etc.), or a history of clinically significant hypersensitivity A subject with a history of gastrointestinal disorders (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or surgery (except for simple appendectomy and herniotomy) that may affect the safety and pharmacokinetics of the investigational products A subject with the following results in the screening test: Blood AST (GOT), ALT (GPT): > Normal range upper × 1.5 QTc interval: > 450 ms Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test) A subject with systolic blood pressure < 80 mmHg or > 160 mmHg, or diastolic blood pressure < 50 mmHg or > 100 mmHg when vital signs are measured in sitting position after resting for at least 3 minutes A subject with a history of drug abuse A subject who administered any prescription drugs or herbal medicine within 2 weeks prior to the expected date of the first dose, or any over-the-counter drug (OTC drug, health functional food or vitamin within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise decided eligible by the investigator), or is expected to administer it A subject who administered drugs that induce (such as barbitals) or inhibit (such as clarithromycin) the drug metabolizing enzymes within 1 month prior to the expected date of the first dose A subject who participated in other clinical trial or bioequivalence study within 6 months prior to the expected date of the first dose A subject who donated whole blood within 2 months or the component blood within 1 month prior to the expected date of the first dose, or received blood transfusion within 1 month prior to the expected date of the first dose A subject with persistent alcohol intake (> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to abstain from drinking from 3 days before the expected date of the first dose until the last discharge A subject with inability to refrain from grapefruit-containing food from 3 days before the expected date of the first dose until the last discharge A subject with excessive caffeine intake (> 5 units/day), or inability to refrain from caffeine or caffeine-containing food from 3 days before the expected date of the first dose until the last discharge A subject with inability to use a medically acceptable double contraception or contraception throughout the study and for at least 4 weeks after the last dose, and with inability to agree to donate sperm until the period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SeungHwan Lee, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study to Evaluate Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers

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