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Completed

NCT Number: NCT04942652

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

The aim of this study is to evaluate the effects of food or proton pump inhibitor on the pharmacokinetics of itraconazole in healthy volunteers.

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Key information

Conditions

Achlorhydria Acid-Base Imbalance Digestive System Diseases Gastrointestinal Diseases Metabolic Diseases Nutritional and Metabolic Diseases Stomach Diseases

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Itraconazole 200 mg

Drug

Itraconazole 100 mg capsule x 2

Other names: Sporanox capsule

esomeprazole 40 mg

Drug

Esomeprazole 40 mg tablet x 1

Other names: Nexium

Primary outcomes

  1. Cmax 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

    Pharmacokinetic parameters of itraconazole

  2. AUClast 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

    Pharmacokinetic parameters of itraconazole

  3. AUCinf 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

    Pharmacokinetic parameters of itraconazole

  4. Tmax 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

    Pharmacokinetic parameters of itraconazole

  5. t1/2 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

    Pharmacokinetic parameters of itraconazole

  6. CL/F 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

    Pharmacokinetic parameters of itraconazole

  7. Vd/F 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

    Pharmacokinetic parameters of itraconazole

  8. Cmax 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

    Pharmacokinetic parameters of hydroxy-itraconazole

  9. AUClast 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

    Pharmacokinetic parameters of hydroxy-itraconazole

  10. AUCinf 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

    Pharmacokinetic parameters of hydroxy-itraconazole

  11. Tmax 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

    Pharmacokinetic parameters of hydroxy-itraconazole

  12. t1/2 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

    Pharmacokinetic parameters of hydroxy-itraconazole

  13. metabolic ratio 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

    Pharmacokinetic parameters of hydroxy-itraconazole

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2021
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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