Tegoprazan-Aspirin Drug Interaction in Healthy Adult Male Volunteers

NCT07853248 | Not Yet Recruiting Phase 1

• 1 other identifier: IN_APA_122
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This Clinical Trial Aims to Evaluate the PK/PD Drug-Drug Interaction and Safety/Tolerability of Tegoprazan and Aspirin in Healthy Adult Male Volunteers.

Conditions

Healthy Adult Male

Outcome Measures

Primary Outcomes (6)

• Cmax,ss of Aspirin

  PK parameter of Aspirin

  Day 1-Day 5, Day 22-Day 25 up to 24 hours

• AUCtau,ss of Aspirin

  PK parameter of Aspirin

  Day 1-Day 5, Day 22-Day 25 up to 24 hours

• Cmax,ss of Tegoprazan

  PK parameter of Tegoprazan

  Day 16-Day 20, Day 22-Day 25 up to 24 hours

• AUCtau,ss of Tegoprazan

  PK parameter of Tegoprazan

  Day 16-Day 20, Day 22-Day 25 up to 24 hours

• Inhibition of Platelet Aggregation (%)

  PD parameter of Aspirin

  Predose on Day 1 and 24 hours after the Day 5 dose; and predose on Day 21 and 24 hours after the Day 25 dose

• Inhibition of Thromboxane B2 (%)

  PD parameter of Aspirin

  Predose on Day 1 and 24 hours after the Day 5 dose; and predose on Day 21 and 24 hours after the Day 25 dose

Study Arms (1)

Aspirin-Tegoprazan Sequence

EXPERIMENTAL

Period 1 (Day 1-Day 5): Participants receive aspirin 100 mg Period 2 (Day 16-Day 20): Participants receive tegoprazan 50 mg Period 3 (Day 21-Day 25): Participants receive tegoprazan 50 mg and aspirin 100 mg

Drug: Aspirin; Drug: Tegoprazan; Drug: Tegoprazan + Aspirin

Interventions

Aspirin DRUG

QD, for 5 days

Also known as: Aspirin Protect Tab. 100 mg

Aspirin-Tegoprazan Sequence

Tegoprazan DRUG

QD, for 5 days

Also known as: K-CAB Tab. 50 mg

Aspirin-Tegoprazan Sequence

Tegoprazan + Aspirin DRUG

QD, for 5 days

Aspirin-Tegoprazan Sequence

Eligibility Criteria

• Age: 19 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male adult volunteers aged ≥19 years and ≤50 years at the time of screening
• Participants who weigh ≥50.0 kg and ≤90.0 kg at the time of screening and have a body mass index (BMI, Body Mass Index) of ≥18.5 kg/m² and ≤29.9 kg/m²
• Participants who, after receiving a sufficient explanation of and fully understanding this clinical trial, voluntarily decide to participate and provide written consent to comply with the precautions
• Participants who are determined to be negative in the Helicobacter pylori Antibody test
• Participants considered eligible for participation in this clinical trial by the investigator based on physical examination, clinical laboratory tests, medical interview, etc.

You may not qualify if:

• Participants who have or have a history of clinically significant hepatobiliary diseases (e.g., severe hepatic impairment or viral hepatitis), renal diseases (e.g., severe renal impairment), neurological diseases, immune system disorders, respiratory diseases, gastrointestinal diseases, endocrine disorders, hematologic or neoplastic diseases, cardiovascular diseases (e.g., cardiac failure or Torsade de pointes), urinary system disorders, psychiatric disorders (e.g., mood disorder or obsessive-compulsive disorder), sexual dysfunction, or other relevant diseases
• Participants who have a history of gastrointestinal diseases (e.g., Crohn's disease, ulcer, gastritis, gastric spasm, or gastroesophageal reflux disease) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the evaluations of the safety, pharmacokinetics, and pharmacodynamics of the investigational product
• Participants who have hypersensitivity to P-CAB (Potassium-Competitive Acid Blocker), drugs of the same class, or any other drugs (e.g., Aspirin or other salicylates, antibiotics, or benzimidazole anthelmintics), or who have a history of clinically significant hypersensitivity
• Participants with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• Participants with positive serology results for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis
• Participants with a history of drug abuse or who test positive for drugs of abuse in a urine drug screening test
• Participants with any of the following vital sign values measured in the sitting position after at least 3 minutes of rest at screening:
• Systolic blood pressure \< 80 mmHg or ≥ 140 mmHg
• Diastolic blood pressure \< 45 mmHg or ≥ 90 mmHg
• Participants with QTcB \> 450 msec or clinically significant abnormal rhythm findings on 12-lead ECG at screening
• Participants with one or more of the following results in clinical laboratory tests conducted during screening, including additional tests:
• AST (SGOT) or ALT (SGPT) \> 1.5 x the upper limit of the normal range
• Estimated glomerular filtration rate (eGFR, CKD-EPI equation) \< 90 mL/min/1.73m²
• Blood platelet count \< 130,000/μL, PT INR \> 1.2, or aPTT \> 36.4 sec
• Participants who have taken any prescription drug or herbal medicine within 2 weeks prior to the scheduled date of the first administration of the investigational product, or any OTC drug, health functional food including liver function supplements, or vitamin preparation within 1 week prior to the scheduled date of the first administration of the investigational product (however, participants may be enrolled if other conditions are deemed reasonable by the investigator), or who are expected to take any such product

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Seoul National University Hospital, Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Aspirin; tegoprazan

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• SeungHwan Lee

  Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heeju Ahn

CONTACT

+82 31-5176-4662; heeju.ahn21@inno-n.com

Yugyeong Park

CONTACT

+82 31-5176-4661; yugyeong.park@inno-n.com

Study Design

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

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): October 14, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

KR (1)