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Gastroesophageal Reflux DiseasePhase 1NCT04568772

Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers

A Phase 1 study testing Atovaquone / Proguanil 250/100 mg, Tegoprazan 50 mg and Esomeprazole 40 mg in people with Gastroesophageal Reflux Disease, run by Seoul National University Hospital at 1 site in South Korea.

Completed

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

Official record
Search all trials

Trial summary

The aim of this study is to evaluate the influence of tegoprazan on the pharmacokinetics of proguanil in healthy volunteers. Read more about this study

Who is it for?
Ages 19 to 50 years
Conditions the study is for
Gastroesophageal Reflux Disease
What is being tested?
Atovaquone / Proguanil 250/100 mg, Tegoprazan 50 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
19 participants
Where
1 siteSouth Korea
Study dates
25 Nov 2020to 3 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
  • No healthy volunteers
  • 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
  • Extensive metabolizer (*1/*1) by CYP2C19 genotyping
  • 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
  • Creatinine clearance calculated by MDRD equation: < 80mL/min
Show all 20Show fewer
  • QTc interval: > 450 ms
  • Fasting serum glucose: > 126 mg/dL
  • Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test)
  • A subject with systolic blood pressure < 90 mmHg or > 150 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 or positive urine screening for 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 or inhibit the drug metabolizing enzymes, such as barbitals, within 1 week 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 who is a currently smoker (But, can be eligible if he or she quitted smoking 3 months ago), or is not able to cease smoking from 3 months 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, Clinical Trial Center

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Three-period Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers

The aim of this study is to evaluate the influence of tegoprazan on the pharmacokinetics of proguanil in healthy volunteers.

Read the detailed description

Evaluation criteria

  • Pharmacokinetic assessment with plasma concentrations of proguanil and cycloguanil
  • Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory tests
Being tested
Atovaquone / Proguanil 250/100 mg, Tegoprazan 50 mg, Esomeprazole 40 mg, Vonoprazan 20 mg
Medical subject headings
Gastroesophageal Reflux

What participants receive

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

  • Atovaquone / Proguanil 250/100 mgDrug

    Also called Malarone

    Atovaquone / Proguanil 250/100 mg tablet

  • Tegoprazan 50 mgDrug

    Also called K-cab

    Tegoprazan 50 mg tablet

  • Esomeprazole 40 mgDrug

    Also called Nexium

    Esomeprazole 40 mg tablet

  • Vonoprazan 20 mgDrug

    Also called Takecab

    Vonoprazan 20 mg tablet

Study groups in NCT04568772
Study groupRoleWhat they receive
Atovaquone/Proguanil 250/100 mgActive comparatorA single oral administration of atovaquone/proguanil 250/100 mg
Receives: Drug: Atovaquone / Proguanil 250/100 mg
Tegoprazan 50 mg + Atovaquone/Proguanil 250/100 mgExperimentalOral administration of tegoprazan 50 mg once daily for 6 days and then co-administration of tegoprazan 50 mg and atovaquone/proguanil 250/100 mg at 7 day
Receives: Drug: Atovaquone / Proguanil 250/100 mg; Drug: Tegoprazan 50 mg
Esomeprazole 40 mg + Atovaquone/Proguanil 250/100 mgExperimentalOral administration of esomeprazole 40 mg once daily for 6 days and then co-administration of esomeprazole 40 mg and atovaquone/proguanil 250/100 mg at 7 day
Receives: Drug: Atovaquone / Proguanil 250/100 mg; Drug: Esomeprazole 40 mg
Vonoprazan 20 mg + Atovaquone/Proguanil 250/100 mgExperimentalOral administration of vonoprazan 20 mg once daily for 6 days and then co-administration of vonoprazan 20 mg and atovaquone/proguanil 250/100 mg at 7 day
Receives: Drug: Atovaquone / Proguanil 250/100 mg; Drug: Vonoprazan 20 mg

What is being measured

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

  1. AUClast of proguanil, cycloguanil

    Systemic exposure of proguanil and cycloguanil

    Measured: Pre-dose(0 hour) and up to 48 hours in each period

Secondary outcomes (8)

  1. Cmax of proguanil

    Secondary pharmacokinetic parameters of proguanil

    Measured: Pre-dose(0 hour) and up to 48 hours in each period

  2. AUCinf of proguanil

    Secondary pharmacokinetic parameters of proguanil

    Measured: Pre-dose(0 hour) and up to 48 hours in each period

  3. Tmax of proguanil

    Secondary pharmacokinetic parameters of proguanil

    Measured: Pre-dose(0 hour) and up to 48 hours in each period

  4. t1/2 of proguanil

    Secondary pharmacokinetic parameters of proguanil

    Measured: Pre-dose(0 hour) and up to 48 hours in each period

  5. CL/F of proguanil

    Secondary pharmacokinetic parameters of proguanil

    Measured: Pre-dose(0 hour) and up to 48 hours in each period

  6. Vz/F of proguanil

    Secondary pharmacokinetic parameters of proguanil

    Measured: Pre-dose(0 hour) and up to 48 hours in each period

  7. fe of proguanil

    Secondary pharmacokinetic parameters of proguanil

    Measured: Pre-dose(0 hour) and up to 48 hours in each period

  8. CLR of proguanil

    Secondary pharmacokinetic parameters of proguanil

    Measured: Pre-dose(0 hour) and up to 48 hours in each period

Timeline

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

  1. First posted29 Sep 2020
  2. Study start25 Nov 2020
  3. Primary completion8 Jul 2021
  4. Study completion3 Aug 2021

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04568772
Sponsor's protocol ID
Tegoprazan_CYP2C19_DDI
Status last verified
Sep 2021
First submitted
15 Sep 2020
Last updated
27 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yang E, Ji SC, Jang IJ, Lee S. Evaluation of CYP2C19-Mediated Pharmacokinetic Drug Interaction of Tegoprazan, Compared with Vonoprazan or Esomeprazole. Clin Pharmacokinet. 2023 Apr;62(4):599-608. doi: 10.1007/s40262-023-01228-4. Epub 2023 Mar 10.

    PubMed 36897544

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atovaquone / Proguanil 250/100 mg, Tegoprazan 50 mg and Esomeprazole 40 mg in people with Gastroesophageal Reflux Disease, 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 6 inclusion and 20 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 27 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?

AUClast of proguanil, cycloguanil (time frame: Pre-dose(0 hour) and up to 48 hours in each period). 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 NCT04568772, which also lists 1 linked publication.

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 27 Sep 2021.

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