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HealthyPhase 1NCT04587011

A Study to Explore Pharmacokinetics/Pharmacodynamics and Safety of Tegoprazan BID Dosing in Healthy Subjects

A Phase 1 study of Healthy, run by HK inno.N Corporation at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The main purpose of this study is to explore the pharmacokinetics, pharmacodynamics and safety after twice-daily dosing of tegoprazan tablets in healthy subjects. Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSouth Korea
Study dates
24 Sep 2020to Jun 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects aged 19 to 45(inclusive) years at screening.
  • Subjects with body mass index (BMI) in the range of 18.5 kg/m^2 to 28.0 kg/m^2(inclusive)
  • Subjects who voluntarily agreed to participate in the study after being fully informed of the purpose, content, and characteristics of the investigational product(IP) prior to the study participation.

Who cannot join

  • Past medical history
  • Subjects who are determined by the investigator to have clinically significant history or disease related to the liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system, urinary system and cardiovascular system including cardiac arrhythmia.
  • Subjects who are determined by the investigator to have past history of gastrointestinal diseases (ex.: gastritis, GERD, Crohn's disease, ulcers etc.) or abdominal surgery (except simple appendectomy or herniotomy) that may affect the IP absorption.
  • Diagnostic test and electrocardiogram (ECG)
  • If H. pylori test result is positive at screening
  • If the AST or ALT value is more than 1.25 times the upper limit of normal under the screening test
Show all 27Show fewer
  • If the total bilirubin value is more than 1.5 times the upper limit of normal under the screening test
  • If the eGFR calculated by CKD-EPI formula is less than 80 mL/min at screening
  • Subjects showing clinically significant abnormalities on ECG at screening
  • Allergy and drug abuse
  • Subjects who are hypersensitive to the investigational product or its active ingredient and any other medications (aspirin, antibiotics etc.)
  • Subjects with history of substance abuse or positive results from drug screening test.
  • Contraindicated drugs/foods
  • Subjects who have been taking any medications (including herbal medicines) or on an abnormal diet (ex: consuming more than 1L of grapefruit juice per day, large amounts of garlic, broccoli and kale, etc.) that can affect the absorption, distribution, metabolism and excretion of the IP within 28 days from the first IP administration date
  • Subjects who took any prescription drugs(ETC) or any over-the-counter drugs(OTC) within 10 days from the first IP administration date
  • Subjects who participated in other clinical trials or bioequivalence test and received other investigational product within 6 months from the first day of the IP administration (allowed to participate only if the other investigational product(s) was(were) not taken)
  • Blood donation and transfusion
  • Subjects who donated whole blood within 60 days from the first day of the investigational product administration
  • Subjects who received blood transfusion or made apheresis blood donation within 30 days from the first day of the IP administration
  • Pregnancy, Breastfeeding, and Contraception
  • Women who are pregnant, breast-feeding or have positive result on pregnancy test.
  • Subjects who are unable to use medically proven dual contraceptive methods or medically acceptable contraceptive method (intrauterine device with proven pregnancy failure rate, concurrent use of physical barrier method and spermicide, vasectomy, tubectomy/ligation, and hysterectomy, etc.) by the subject or spouse or partner from the screening date to 30 days after the last IP administration date.
  • Others
  • Subjects whose weekly alcohol intake exceeds 30g/day in the last 4 weeks prior to the screening visit or found positive on alcohol test
  • Subjects who smoke more than 10 cigarettes/day per week over the last 4 weeks prior to the screening visit
  • Subjects with caffeine consumption of more than 400mg/day per week over the last 4 weeks prior to the screening visit
  • Subjects with clinically significant findings that the investigator determined to be unqualified for participation in the clinical trial

Trial locations and contacts

1 site in 1 country.

Youngshin Keum, R.Ph, Pharm.D contact

+82-2-6477-0204

ys.keum@inno-n.com

Seokuee Kim, MD, PhD contact

+82-2-6477-0207

seokuee.kim@inno-n.com

South Korea1 site, 1 recruiting

  • Inje University Busan Paik Hospital

    Busan, 47392

    Jon Lyul Kim, MD, PhD

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase 1 Clinical Trial to Explore Pharmacokinetics, Pharmacodynamics and Safety After Twice-daily Dosing of Tegoprazan Tablets in Healthy Subjects

The main purpose of this study is to explore the pharmacokinetics, pharmacodynamics and safety after twice-daily dosing of tegoprazan tablets in healthy subjects.

Read the detailed description
  • To explore the pharmacokinetics, pharmacodynamics and safety in accordance with the dose escalation when tegoprazan is given orally twice daily for 3 days in healthy subjects.
  • To compare the pharmacodynamics and safety of tegoprazan oral administration and esomeprazole infusion for 24 hours
Conditions
Healthy
Being tested
Tegoprazan dose A or placebo, Tegoprazan dose B or placebo, Tegoprazan dose C or placebo, Tegoprazan dose D or placebo

What participants receive

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

  • Tegoprazan dose A or placeboDrug

    Tegoprazan A mg or placebo taken orally twice daily for 3 days.

  • Tegoprazan dose B or placeboDrug

    Tegoprazan B mg or placebo taken orally twice daily for 3 days.

  • Tegoprazan dose C or placeboDrug

    Tegoprazan C mg or placebo taken orally twice daily for 3 days.

  • Tegoprazan dose D or placeboDrug

    Tegoprazan D mg or placebo taken orally twice daily for 3 days.

Study groups in NCT04587011
Study groupRoleWhat they receive
T1ExperimentalTegoprazan A mg or placebo
Receives: Drug: Tegoprazan dose A or placebo
T2ExperimentalTegoprazan B mg or placebo
Receives: Drug: Tegoprazan dose B or placebo
T3ExperimentalTegoprazan C mg or placebo
Receives: Drug: Tegoprazan dose C or placebo
T4ExperimentalTegoprazan D mg or placebo
Receives: Drug: Tegoprazan dose D or placebo

What is being measured

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

  1. Pharmacokinetics Evaluation

    Cmax of Tegoprazan and M1

    Measured: Up to 24 hours

  2. Pharmacokinetics Evaluation

    AUC0-t of Tegoprazan and M1

    Measured: Up to 24 hours

  3. Pharmacokinetics Evaluation

    AUC0-∞ of Tegoprazan and M1

    Measured: Up to 24 hours

  4. Pharmacokinetics Evaluation

    Tmax of Tegoprazan and M1

    Measured: Up to 24 hours

  5. Pharmacokinetics Evaluation

    t1/2β of Tegoprazan and M1

    Measured: Up to 24 hours

  6. Pharmacokinetics Evaluation

    CL/F of Tegoprazan

    Measured: Up to 24 hours

  7. Pharmacokinetics Evaluation

    Vd/F of Tegoprazan

    Measured: Up to 24 hours

  8. Pharmacokinetics Evaluation

    Css,max of Tegoprazan and M1

    Measured: Up to 24 hours

  9. Pharmacokinetics Evaluation

    Css,min of Tegoprazan and M1

    Measured: Up to 24 hours

  10. Pharmacokinetic Evaluation

    Css,avg of Tegoprazan and M1

    Measured: Up to 24 hours

  11. Pharmacokinetics Evaluation

    AUC48-72h of Tegoprazan and M1

    Measured: Up to 24 hours

  12. Pharmacokinetics Evaluation

    Tmax,ss of Tegoprazan and M1

    Measured: Up to 24 hours

  13. Pharmacokinetics Evaluation

    t1/2β,ss of Tegoprazan and M1

    Measured: Up to 24 hours

  14. Pharmacokinetics Evaluation

    CLss/F of Tegoprazan

    Measured: Up to 24 hours

  15. Pharmacokinetics Evaluation

    Vdss/F of Tegoprazan

    Measured: Up to 24 hours

Secondary outcomes (9)

  1. Pharmacodynamics Evaluation

    Mean pH

    Measured: 24 hours

  2. Pharmacodynamics Evaluation

    Median pH

    Measured: 24 hours

  3. Pharmacodynamics Evaluation

    TpH>4(%)

    Measured: 24 hours

  4. Pharmacodynamics Evaluation

    TpH>6(%)

    Measured: 24 hours

  5. Pharmacodynamics Evaluation

    Basal pH

    Measured: 24 hours

  6. Pharmacodynamics Evaluation

    Δ TpH>4(%)

    Measured: 24 hours

  7. Pharmacodynamics Evaluation

    Δ TpH>6(%)

    Measured: 24 hours

  8. Pharmacodynamics Evaluation

    Δ mean pH

    Measured: 24 hours

  9. Pharmacodynamics Evaluation

    Δ median pH

    Measured: 24 hours

Timeline

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

  1. First posted14 Oct 2020
  2. Study start24 Sep 2020
  3. Primary completionMar 2021 (estimated)
  4. Study completionJun 2021 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04587011
Sponsor's protocol ID
IN_APA_119
Status last verified
Aug 2020
First submitted
7 Oct 2020
Last updated
28 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Healthy, run by HK inno.N Corporation 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 3 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 28 Dec 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Youngshin Keum, R.Ph, Pharm.D (+82-2-6477-0204, ys.keum@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics Evaluation (time frame: Up to 24 hours). The study lists 15 primary outcomes in all. 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 NCT04587011.

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 28 Dec 2020.

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