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HealthyPhase 1NCT06332638

PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects

A Phase 1 study testing Tegoprazan 12.5mg, Tegoprazan 25mg and Famotidine 20mg in people with 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 The sponsor has not verified this record for over two years, so it may be out of date.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 primary objective of this study is to explore pharmacokinetics, pharmacodynamics, and safety of tegoprazan 12.5 mg in healthy subjects when orally administered as a single dose or as multiple doses twice daily. Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Tegoprazan 12.5mg, Tegoprazan 25mg and Famotidine 20mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSouth Korea
Study dates
19 Mar 2024to 31 Jul 2024
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 adults aged ≥ 19 years to ≤ 45 years at the time of screening testing
  • Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 28.0 kg/m2 (BMI = weight (kg) / height (m)2)
  • Those who have been fully informed of study purpose and procedures, properties of the investigational products(IPs), etc. and have voluntarily decide to participate in this study and signed an informed consent form (ICF), prior to participation in the study

Who cannot join

  • Medical history
  • Previous history or presence of clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, urinary and cardiovascular (including cardiac arrhythmia) disorders in the judgment of the investigator
  • Previous history of gastrointestinal diseases (e.g., gastritis, gastrospasm, gastroesophageal reflux disease (GERD), Crohn's disease, ulcers, etc.) or abdominal surgery (excluding simple appendectomy or hernia surgery) which may affect drug absorption in the judgment of the investigator
  • Presence of anatomical disorders that make it difficult to insert and maintain a catheter for intragastric pH measurement, or expected intolerance to catheterization for intragastric pH measurement
  • Hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Clinical laboratory tests and electrocardiogram (ECG)
Show all 29Show fewer
  • AST or ALT value ≥ 1.5 x upper limit of normal (ULN) as a result of clinical laboratory testing at screening
  • Total bilirubin value ≥ 2.0 x upper limit of normal (ULN) as a result of clinical laboratory testing at screening
  • eGFR value calculated using the CKD-EPI formula < 80 mL/min as a result of clinical laboratory testing at screening
  • Any clinically significant abnormality as a result of ECG at screening
  • Positive test result for H. pylori at screening
  • Allergies and drug abuse
  • History of hypersensitivity to the IPs, components of the IPs, and other drugs (benzimidazoles, H2 receptor antagonists, aspirin, antibiotics, etc.)
  • Previous history of drug abuse or positive drug screening test result
  • Prohibited concomitant medications/diets
  • Consumption of medicines (including herbal medicines) or abnormal diets (e.g., at least 1L/day of grapefruit juice, much garlic, broccoli, kale, etc.) which may affect the absorption, distribution, metabolism, and excretion of the IP within 28 days before the screening visit
  • Administration of the drugs affecting gastric pH within 14 days before the screening visit (including potassium-competitive acid blockers, proton pump inhibitors, H2-receptor antagonists, and antacids) or administration of ethical-the-counter (ETC) drugs, any over-the-counter (OTC) drugs, vitamins, etc. within 10 days before the screening visit
  • Administration of another IP by participating in another clinical trial within 6 months prior to the screening visit (but those who are not administered the IP can participate in this study)
  • Blood donation and transfusion
  • Whole blood donation within 60 days before the screening visit
  • Blood component donation or transfusion within 30 days before the screening visit
  • Pregnancy, breastfeeding, and non-use of contraceptives
  • Pregnant women, women who tested positive for pregnancy, or breastfeeding women
  • Failure to use medically recognized and proper double contraceptive methods or medically acceptable contraceptive methods (intrauterine device showing a demonstrated pregnancy failure rate, combined use of physical barrier method and spermicide, vasectomy, salpingectomy/tubal ligation, hysterectomy, etc.) in the subject or his/her spouse or partner from the date of screening visit until 30 days after the last dose of the IP
  • Others
  • Mean alcohol intake exceeding 30 g/day per week for recent 4 weeks before the screening visit or positive alcohol breath test result
  • Mean number of smoked cigarettes exceeding 10 cigarettes/day per week for recent 4 weeks before the screening visit
  • Mean caffeine intake exceeding 400 mg/day per week for recent 4 weeks before the screening visit
  • Presence of clinically significant findings that make the subject ineligible for this study in the judgment of the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Inje University Busan Paik Hospital

    Busan, 47392

Other trials in South Korea

About this study

Official title: Phase 1 Clinical Trial to Explore Pharmacokinetics, Pharmacodynamics and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects

The primary objective of this study is to explore pharmacokinetics, pharmacodynamics, and safety of tegoprazan 12.5 mg in healthy subjects when orally administered as a single dose or as multiple doses twice daily.

Read the detailed description

The secondary objectives of this study are

  • To compare pharmacokinetics and pharmacodynamics of tegoprazan 12.5 mg in healthy subjects between oral multiple-dose administration twice daily for 1 day and oral single-dose administration.
  • To evaluate pharmacokinetics and pharmacodynamics of tegoprazan 12.5 mg administered orally twice daily for 14 days in healthy subjects in comparison with tegoprazan 25 mg administered orally once daily for 14 days in healthy subjects.
  • To evaluate pharmacodynamics of tegoprazan 12.5 mg administered orally twice daily for 14 days or tegoprazan 25 mg administered orally once daily for 14 days in healthy subjects in comparison with famotidine 20 mg administered orally twice daily for 14 days in healthy subjects.
Conditions
Healthy
Being tested
Tegoprazan 12.5mg, Tegoprazan 25mg, Famotidine 20mg

What participants receive

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

  • Tegoprazan 12.5mgDrug

    Also called Tegoprazan Tab. 12.5mg

    Oral administration of one tablet of Tegoprazan 12.5mg twice daily for 14 days.

  • Tegoprazan 25mgDrug

    Also called K-CAB Tab. 25mg

    Oral administration of one tablet of Tegoprazan 25mg once daily for 14 days.

  • Famotidine 20mgDrug

    Also called Gaster Tab. 20 mg Dong-A

    Oral administration of one tablet of Famotidine 20mg twice daily for 14 days.

Study groups in NCT06332638
Study groupRoleWhat they receive
Group AExperimentalTegoprazan 12.5mg
Receives: Drug: Tegoprazan 12.5mg
Group BActive comparatorTegoprazan 25mg
Receives: Drug: Tegoprazan 25mg
Group CActive comparatorFamotidine 20mg
Receives: Drug: Famotidine 20mg

What is being measured

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

  1. Cmax of tegoprazan and tegoprazan's metabolite M1

    Pharmacokinetic evaluation (Day 1)

    Measured: Pre-dose(0 hour) up to 24 hours on Day 1

  2. AUC0-t of tegoprazan and tegoprazan's metabolite M1

    Pharmacokinetic evaluation (Day 1)

    Measured: Pre-dose(0 hour) up to 24 hours on Day 1

  3. AUC0-∞ of tegoprazan and tegoprazan's metabolite M1

    Pharmacokinetic evaluation (Day 1)

    Measured: Pre-dose(0 hour) up to 24 hours on Day 1

  4. Tmax of tegoprazan and tegoprazan's metabolite M1

    Pharmacokinetic evaluation (Day 1)

    Measured: Pre-dose(0 hour) up to 24 hours on Day 1

  5. t1/2β of tegoprazan and tegoprazan's metabolite M1

    Pharmacokinetic evaluation (Day 1)

    Measured: Pre-dose(0 hour) up to 24 hours on Day 1

  6. CL/F of tegoprazan

    Pharmacokinetic evaluation (Day 1)

    Measured: Pre-dose(0 hour) up to 24 hours on Day 1

  7. Vd/F of tegoprazan

    Pharmacokinetic evaluation (Day 1)

    Measured: Pre-dose(0 hour) up to 24 hours on Day 1

  8. Css,max of tegoprazan and tegoprazan's metabolite M1

    Pharmacokinetic evaluation (Day 14)

    Measured: Pre-dose(morning) (-12, 0 hour) up to 24 hours on Day 14

  9. Css,min of tegoprazan and tegoprazan's metabolite M1

    Pharmacokinetic evaluation (Day 14)

    Measured: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14

  10. Css,avg of tegoprazan and tegoprazan's metabolite M1

    Pharmacokinetic evaluation (Day 14)

    Measured: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14

  11. AUCtau,ss of tegoprazan and tegoprazan's metabolite M1

    Pharmacokinetic evaluation (Day 14)

    Measured: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14

  12. Tmax,ss of tegoprazan and tegoprazan's metabolite M1

    Pharmacokinetic evaluation (Day 14)

    Measured: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14

  13. t1/2β,ss of tegoprazan and tegoprazan's metabolite M1

    Pharmacokinetic evaluation (Day 14)

    Measured: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14

  14. CLss/F of tegoprazan

    Pharmacokinetic evaluation (Day 14)

    Measured: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14

  15. Vdss/F of tegoprazan

    Pharmacokinetic evaluation (Day 14)

    Measured: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14

  16. Accumulation index of tegoprazan

    Pharmacokinetic evaluation (Day 14)

    Measured: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14

  17. Fluctuation of tegoprazan

    Pharmacokinetic evaluation (Day 14)

    Measured: Pre-dose(morning)(-12, 0 hour) up to 24 hours on Day 14

Secondary outcomes (8)

  1. 24-hour, daytime and nighttime mean pH

    Pharmacodynamic evaluation

    Measured: 24 hours on Day -1, Day 1, Day 7, and Day 14

  2. 24-hour, daytime and nighttime median pH

    Pharmacodynamic evaluation

    Measured: 24 hours on Day -1, Day 1, Day 7, and Day 14

  3. 24-hour, daytime and nighttime TpH>3(%)

    Pharmacodynamic evaluation

    Measured: 24 hours on Day -1, Day 1, Day 7, and Day 14

  4. 24-hour, daytime and nighttime TpH>4(%)

    Pharmacodynamic evaluation

    Measured: 24 hours on Day -1, Day 1, Day 7, and Day 14

  5. 24-hour, daytime and nighttime Δ TpH>3(%)

    Pharmacodynamic evaluation

    Measured: 24 hours on Day -1, Day 1, Day 7, and Day 14

  6. 24-hour, daytime and nighttime Δ TpH>4(%)

    Pharmacodynamic evaluation

    Measured: 24 hours on Day -1, Day 1, Day 7, and Day 14

  7. 24-hour, daytime and nighttime Δ mean pH

    Pharmacodynamic evaluation

    Measured: 24 hours on Day -1, Day 1, Day 7, and Day 14

  8. 24-hour, daytime and nighttime Δ median pH

    Pharmacodynamic evaluation

    Measured: 24 hours on Day -1, Day 1, Day 7, and Day 14

Timeline

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

  1. First posted27 Mar 2024
  2. Study start19 Mar 2024
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Jul 2024 (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
Parallel groups
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06332638
Sponsor's protocol ID
IN_APA_124
Status last verified
Mar 2024
First submitted
20 Feb 2024
Last updated
27 Mar 2024
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 testing Tegoprazan 12.5mg, Tegoprazan 25mg and Famotidine 20mg in people with 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 29 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 27 Mar 2024. 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?

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 tegoprazan and tegoprazan's metabolite M1 (time frame: Pre-dose(0 hour) up to 24 hours on Day 1). The study lists 17 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 NCT06332638.

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 Mar 2024.

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