Healthy Adult Male
Conditions
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.
Detailed description
Trial Objective 1. Primary Objective * To evaluate the effect of Tegoprazan on the PK and PD of Aspirin following coadministration of Tegoprazan and Aspirin in healthy male adult participants. * To evaluate the effect of Aspirin on the PK of Tegoprazan following coadministration of Tegoprazan and Aspirin in healthy male adult participants. 2. Secondary Objective * To evaluate the safety and tolerability of Tegoprazan and Aspirin when coadministered in healthy male adult participants. 3. Exploratory Objective * To perform an exploratory evaluation of the concentrations and interconversion characteristics of isomers(R-form and S-form) in blood to explore the in vivo biotransformation profile of Tegoprazan and its metabolites in healthy male adult participants.
Interventions
Sponsors
HK inno.N Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male adult volunteers aged ≥19 years and ≤50 years at the time of screening 2. 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 3. 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 4. Participants who are determined to be negative in the Helicobacter pylori Antibody test 5. Participants considered eligible for participation in this clinical trial by the investigator based on physical examination, clinical laboratory tests, medical interview, etc.
Exclusion criteria
1. 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 2. 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 3. 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 4. Participants with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 5. Participants with positive serology results for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis 6. Participants with a history of drug abuse or who test positive for drugs of abuse in a urine drug screening test 7. 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 8. Participants with QTcB \> 450 msec or clinically significant abnormal rhythm findings on 12-lead ECG at screening 9. 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 10. 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 11. Participants who have taken drug-metabolizing enzyme-inducing drugs, such as barbiturates, or drug metabolism-inhibiting drugs, such as clarithromycin, within 1 month prior to the scheduled date of the first administration of the investigational product 12. Participants who have participated in another clinical trial (including a bioequivalence trial) and received an investigational product within 6 months prior to the scheduled date of the first administration of the investigational product 13. Participants who have donated whole blood within 2 months, or who have donated blood components or received a blood transfusion within 1 month prior to the scheduled date of the first administration of the investigational product. 14. Participants (however, participants who stopped smoking at least 3 months prior to the scheduled date of the first administration of the investigational product may be enrolled), or heavy smokers (10 cigarettes/day), or participants who are unable to abstain from smoking until the end of the clinical trial 15. Participants who regularly consume alcohol (\>21 units/week; 1 unit = 10 g of pure alcohol) or are unable to abstain from alcohol from 3 days prior to the scheduled date of the first administration of the investigational product until the end of the clinical trial 16. Participants who have regularly consumed excessive caffeine (\>5 units/day; 1 unit = 80 mg of caffeine) or are unable to refrain from consuming caffeine-containing foods or beverages (e.g., coffee, tea (including black tea and green tea), carbonated beverages, coffee beverages, coffee milk, tonic drinks, and energy drinks) from 3 days prior to the scheduled date of the first administration of the investigational product until the end of the clinical trial 17. Participants who have consumed or are unable to refrain from consuming grapefruit, grapefruit juice, or grapefruit-containing foods from 3 days prior to the scheduled date of the first administration of the investigational product until the end of the clinical trial 18. Participants who have unusual dietary habits (e.g., consumption of ≥1 L of grapefruit juice per day) or are unable to consume the standardized diet provided by the Clinical Trials Center during the inpatient period 19. Participants who, or whose spouse or partner, are unable to use a contraceptive method considered highly effective throughout the entire clinical trial and for at least 4 weeks after the last administration of the investigational product, and participants who do not agree not to donate sperm during that period \[Contraceptive Methods Considered Highly Effective\] * Intrauterine device, intrauterine hormone-releasing system * Bilateral tubal occlusion * Sexual abstinence, only when defined as refraining from heterosexual intercourse throughout the entire period of risk. 20. Participants determined by the investigator to be unsuitable for participation in this clinical trial for reasons other than those listed above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,ss of Aspirin | Day 1-Day 5, Day 22-Day 25 up to 24 hours | PK parameter of Aspirin |
| AUCtau,ss of Aspirin | Day 1-Day 5, Day 22-Day 25 up to 24 hours | PK parameter of Aspirin |
| Cmax,ss of Tegoprazan | Day 16-Day 20, Day 22-Day 25 up to 24 hours | PK parameter of Tegoprazan |
| AUCtau,ss of Tegoprazan | Day 16-Day 20, Day 22-Day 25 up to 24 hours | PK parameter of Tegoprazan |
| Inhibition of Platelet Aggregation (%) | 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 | PD parameter of Aspirin |
| Inhibition of Thromboxane B2 (%) | 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 | PD parameter of Aspirin |
Countries
South Korea
Contacts
CONTACTHeeju Ahn
CONTACTYugyeong Park
PRINCIPAL_INVESTIGATORSeungHwan Lee
Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital
Outcome results
None listed