A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers

NCT07277712 | Not Yet Recruiting Phase 1

• 1 other identifier: IN_TNA_101
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the pharmacokinetic (PK) following administration of IN-M00002 tablet and co-administration of tegoprazan and naproxen, and to evaluate food-effect of IN-M00002 tablet in healthy adult volunteers

Conditions

Healthy Volunteer

Keywords

pharmacokinetic; food-effect

Outcome Measures

Primary Outcomes (4)

• AUCt of tegoprazan

  Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration

  Up to 48 hours

• AUCt of naproxen

  Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration

  Up to 72 hours

• Cmax of tegoprazan

  Maximum plasma concentration of tegoprazan

  Up to 48 hours

• Cmax of naproxen

  Maximum plasma concentration of naproxen

  Up to 72 hours

Study Arms (4)

Part A: Sequence 1 (Treatment A - Treatment B)

EXPERIMENTAL

Period 1: Single dose of tegoprazan 25 mg QD in combination with naproxen 500 mg BID Period 2: Single dose of IN-M00002 tablet BID

Drug: Tegoprazan; Drug: Naproxen; Drug: IN-M00002

Part A: Sequence 2 (Treatment B - Treatment A)

EXPERIMENTAL

Period 1: Single dose of IN-M00002 tablet BID Period 2: Single dose of tegoprazan 25 mg QD in combination with naproxen 500 mg BID

Drug: Tegoprazan; Drug: Naproxen; Drug: IN-M00002

Part B: Sequence 1 (Treatment C - Treatment D)

EXPERIMENTAL

Period 1: Single dose of IN-M00002 tablet QD under fasted conditions Period 2: Single dose of IN-M00002 tablet QD under fed conditions

Drug: IN-M00002

Part B: Sequence 2 (Treatment D - Treatment C)

EXPERIMENTAL

Period 1: Single dose of IN-M00002 tablet QD under fed conditions Period 2: Single dose of IN-M00002 tablet QD under fasted conditions

Drug: IN-M00002

Interventions

Tegoprazan DRUG

Tegoprazan 25 mg QD

Also known as: K-CAB

Part A: Sequence 1 (Treatment A - Treatment B); Part A: Sequence 2 (Treatment B - Treatment A)

Naproxen DRUG

Naproxen 500 mg BID

Also known as: Naxen-F

Part A: Sequence 1 (Treatment A - Treatment B); Part A: Sequence 2 (Treatment B - Treatment A)

IN-M00002 DRUG

IN-M00002 tablet QD

Part B: Sequence 1 (Treatment C - Treatment D); Part B: Sequence 2 (Treatment D - Treatment C)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult aged ≥ 19 and ≤ 55 year-old at screening
• Body mass index (BMI) ≥ 19.0 kg/m2 and ≤ 27.0 kg/m2 with a body weight ≥ 45 kg at screening
• Those determined to be eligible for this study based on the findings of screening such as clinical laboratory tests (hematological test, blood chemistry test, blood coagulation test, urinalysis, test for viruses/bacteria, etc.), vital signs, and electrocardiogram (ECG) which are performed by the investigator according to the properties of medicines
• Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening
• Those with a capability/willingness to participate throughout the study

You may not qualify if:

• Medical history or evidence of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological, musculoskeletal, oncological, or immune disease (except for history of simple dental treatment such as tartar, impacted teeth, and third molar teeth)
• Previous history of gastrointestinal disease (esophageal disease such as esophageal achalasia or esophageal stricture, inflammatory bowel disease (Crohn's disease, ulcerative colitis)) or surgery (except for simple appendectomy, hernia surgery, tooth extraction, etc.) which may affect drug absorption
• Sitting systolic blood pressure \< 90 mmHg or ≥ 140 mmHg or diastolic blood pressure \< 60 mmHg or ≥ 90 mmHg at screening
• Following findings of clinical laboratory tests:
• ALT or AST value \> twice the upper limit of normal (ULN)
• History of periodic alcohol consumption exceeding 210 g/week within 6 months prior to screening (beer (5%) 1 glass (250 mL) = 10 g, soju (20%) 1 glass (50 mL) = 8 g, wine (12%) 1 glass (125 mL) = 12 g)
• Has taken any other investigational product within 6 months prior to the first dose of investigational product
• History of serious alcohol or drug misuse and abuse within 1 year prior to screening
• Administration of drugs known to markedly induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose of the investigational product
• Daily use of ≥ 20 cigarettes within 6 months prior to screening
• Administration of a prescription or non-prescription drug within 10 days prior to the first dose of the investigational product
• Whole blood donation within 2 months prior to the first dose of the investigational product or apheresis donation within 1 month prior to the first dose of the investigational product
• Subjects who received a blood transfusion within 1 month prior to the first dose of the investigational product
• Those who may be put at an increased risk due to the administration of the investigational product and study participation or have a severe acute/chronic medical or mental condition which may interfere with the interpretation of study results
• Subjects with a history of hypersensitivity (e.g., asthma, rhinitis, nasal polyps, urticaria, or allergic reactions) to the components of tegoprazan or naproxen, benzimidazole derivatives, aspirin, or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Jeonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Interventions

tegoprazan; Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Seol Ju Moon, MD, Ph.D

  Clinical Pharmacology Center, Jeonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Hee Jung, PhD

CONTACT

+82-31-5176-4653; shee.jung@inno-n.com

Eun Ji Kim

CONTACT

+82-31-5176-4652; eunji.kim24@inno-n.com

Study Design

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

Model Details: \[Part A\] 2-sequence-arm, 2-period crossover study \[Part B\] 2-sequence-arm, 2-period crossover study

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: December 27, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Locations

KR (1)