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

NCT06332638 | Enrolling By Invitation Phase 1

• 1 other identifier: IN_APA_124
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (17)

• Cmax of tegoprazan and tegoprazan's metabolite M1

  Pharmacokinetic evaluation (Day 1)

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

• AUC0-t of tegoprazan and tegoprazan's metabolite M1

  Pharmacokinetic evaluation (Day 1)

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

• AUC0-∞ of tegoprazan and tegoprazan's metabolite M1

  Pharmacokinetic evaluation (Day 1)

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

• Tmax of tegoprazan and tegoprazan's metabolite M1

  Pharmacokinetic evaluation (Day 1)

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

• t1/2β of tegoprazan and tegoprazan's metabolite M1

  Pharmacokinetic evaluation (Day 1)

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

• CL/F of tegoprazan

  Pharmacokinetic evaluation (Day 1)

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

• Vd/F of tegoprazan

  Pharmacokinetic evaluation (Day 1)

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

• Css,max of tegoprazan and tegoprazan's metabolite M1

  Pharmacokinetic evaluation (Day 14)

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

• Css,min of tegoprazan and tegoprazan's metabolite M1

  Pharmacokinetic evaluation (Day 14)

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

• Css,avg of tegoprazan and tegoprazan's metabolite M1

  Pharmacokinetic evaluation (Day 14)

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

• AUCtau,ss of tegoprazan and tegoprazan's metabolite M1

  Pharmacokinetic evaluation (Day 14)

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

• Tmax,ss of tegoprazan and tegoprazan's metabolite M1

  Pharmacokinetic evaluation (Day 14)

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

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

  Pharmacokinetic evaluation (Day 14)

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

• CLss/F of tegoprazan

  Pharmacokinetic evaluation (Day 14)

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

• Vdss/F of tegoprazan

  Pharmacokinetic evaluation (Day 14)

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

• Accumulation index of tegoprazan

  Pharmacokinetic evaluation (Day 14)

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

• Fluctuation of tegoprazan

  Pharmacokinetic evaluation (Day 14)

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

Secondary Outcomes (8)

• 24-hour, daytime and nighttime mean pH

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

• 24-hour, daytime and nighttime median pH

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

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

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

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

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

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

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

Study Arms (3)

Group A

EXPERIMENTAL

Tegoprazan 12.5mg

Drug: Tegoprazan 12.5mg

Group B

ACTIVE COMPARATOR

Tegoprazan 25mg

Drug: Tegoprazan 25mg

Group C

ACTIVE COMPARATOR

Famotidine 20mg

Drug: Famotidine 20mg

Interventions

Tegoprazan 12.5mg DRUG

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

Also known as: Tegoprazan Tab. 12.5mg

Group A

Tegoprazan 25mg DRUG

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

Also known as: K-CAB Tab. 25mg

Group B

Famotidine 20mg DRUG

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

Also known as: Gaster Tab. 20 mg Dong-A

Group C

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

MeSH Terms

Interventions

tegoprazan; Famotidine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jong Lyul Ghim, MD, PhD

  Department of Clinical Pharmacology, Inje University Busan Paik Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 27, 2024
• Study Start: March 19, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

KR (1)