AchlorhydriaPhase 1NCT04942652
Study to Evaluate Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers
A Phase 1 study testing Itraconazole 200 mg and Esomeprazole 40 mg in people with Achlorhydria, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Achlorhydria
- What is being tested?
- Itraconazole 200 mg and Esomeprazole 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2021to 24 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
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
The aim of this study is to evaluate the effects of food or proton pump inhibitor on the pharmacokinetics of itraconazole in healthy volunteers.
Read the 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
- Conditions
- Achlorhydria
- Being tested
- Itraconazole 200 mg, Esomeprazole 40 mg
- Medical subject headings
- Achlorhydria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itraconazole 200 mgDrug
Also called Sporanox capsule
Itraconazole 100 mg capsule x 2
Esomeprazole 40 mgDrug
Also called Nexium
Esomeprazole 40 mg tablet x 1
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole 200 mg under fasted condition | Experimental | A single oral administration of itraconazole 200 mg under fasted condition Receives: Drug: Itraconazole 200 mg |
| Itraconazole 200 mg under fed condition | Experimental | A single oral administration of itraconazole 200 mg under fed condition Receives: Drug: Itraconazole 200 mg |
| Esomeprazole 40 mg + Itraconazole 200 mg under fasted condition | Experimental | Oral administration of esomeprazole 40 mg once daily for 6 days and then a single oral administration of itraconazole 200 mg under fasted condition Receives: Drug: Itraconazole 200 mg; Drug: Esomeprazole 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of itraconazole
Pharmacokinetic parameters of itraconazole
Measured: 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
AUClast of itraconazole
Pharmacokinetic parameters of itraconazole
Measured: 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
AUCinf of itraconazole
Pharmacokinetic parameters of itraconazole
Measured: 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
Tmax of itraconazole
Pharmacokinetic parameters of itraconazole
Measured: 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
t1/2 of itraconazole
Pharmacokinetic parameters of itraconazole
Measured: 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
CL/F of itraconazole
Pharmacokinetic parameters of itraconazole
Measured: 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
Vd/F of itraconazole
Pharmacokinetic parameters of itraconazole
Measured: 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
Cmax of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Measured: 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
AUClast of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Measured: 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
AUCinf of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Measured: 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
Tmax of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Measured: 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
t1/2 of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Measured: 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
metabolic ratio of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start13 Jul 2021
- Primary completion6 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchlorhydriaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SeungHwan Lee, Seoul National University Hospital
- Investigators
- SeungHwan Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942652
- Sponsor's protocol ID
- Itraconazole_pH
- Status last verified
- Sep 2021
- First submitted
- 20 Jun 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04942652
- Acronym / sponsor ID
- Itraconazole_pH
- Conditions
- Achlorhydria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Itraconazole 200 mg under fasted condition | Experimental | Drug: Itraconazole 200 mgA single oral administration of itraconazole 200 mg under fasted condition |
| Itraconazole 200 mg under fed condition | Experimental | Drug: Itraconazole 200 mgA single oral administration of itraconazole 200 mg under fed condition |
| Esomeprazole 40 mg + Itraconazole 200 mg under fasted condition | Experimental | Drug: Itraconazole 200 mg, Drug: Esomeprazole 40 mgOral administration of esomeprazole 40 mg once daily for 6 days and then a single oral administration of itraconazole 200 mg under fasted condition |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
- 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
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 |
|---|---|---|
| Itraconazole 200 mgAlso: Sporanox capsuleItraconazole 100 mg capsule x 2 | Drug | Esomeprazole 40 mg + Itraconazole 200 mg under fasted condition, Itraconazole 200 mg under fasted condition, Itraconazole 200 mg under fed condition |
| Esomeprazole 40 mgAlso: NexiumEsomeprazole 40 mg tablet x 1 | Drug | Esomeprazole 40 mg + Itraconazole 200 mg under fasted condition |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: Undecided
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.
SeungHwan Lee, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Itraconazole 200 mg and Esomeprazole 40 mg in people with Achlorhydria, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 17 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 29 Sep 2021. 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 South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2021.