Safety and Pharmacokinetics Evaluation Study According to the Dose of Camostat Mesylate in Healthy Volunteers

Study Overview
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Brief Summary
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Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy volunteers

Official Title
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A Open-label, Single-dose, Phase 1 Study to Compare and Evaluate the Safety and Pharmacokinetics According to the Dose of Camostat Mesylate in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: DWJ1248


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged ≥ 19 and ≤ 55 years at screening Subjects with body weight of ≥ 55.0 kg and ≤ 90.0 kg, and a body mass index (BMI) of ≥ 18.0 and ≤ 29.9 Subjects who have no congenital or chronic disease and have no pathological symptoms or findings as a result of an internal examination Exclusion Criteria: Subjects with current or prior history of a clinically significant hepatic, renal, nervous, respiratory, gastrointestinal, endocrine, hematologic and oncologic, urogenital, cardiovascular, musculoskeletal or psychiatric disorder Subjects with symptoms of acute disease within 28 days prior to the scheduled first administration date of IP Subjects with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcers, etc.) or gastrointestinal resection (except simple appendectomy or hernia surgery) that may affect the absorption of drugs.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Part1. Parallel, Part2. Crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 (Part 1)<br>DWJ1248 100mg (100mg 1tab) PO | Drug: DWJ1248<br>* Camostat mesylate Tablet from Daewoong<br>|
| Experimental: Cohort 2 (Part 1)<br>DWJ1248 200mg (100mg 2tab) PO | Drug: DWJ1248<br>* Camostat mesylate Tablet from Daewoong<br>|
| Experimental: Cohort 3 (Part 1)<br>DWJ1248 300mg (100mg 3tab) PO | Drug: DWJ1248<br>* Camostat mesylate Tablet from Daewoong<br>|
| Experimental: Group A (Part 2)<br>DWJ1248 100mg 2tab PO - Wash out - DWJ1248 200mg 1tab PO | Drug: DWJ1248<br>* Camostat mesylate Tablet from Daewoong<br>|
| Experimental: Group B (Part 2)<br>DWJ1248 200mg 1tab PO - Wash out - DWJ1248 100mg 2tab PO | Drug: DWJ1248<br>* Camostat mesylate Tablet from Daewoong<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of GBPA | Maximum blood concentration of GBPA (GUANIDINO BENZOYLOXY PHENYLACETIC ACID METHANESULFONATE) among observed blood concentrations at time points Immediately before administration of IP After administration | 0-6 hr | 
| AUClast of GBPA | Area under the blood concentration-time of GBPA (GUANIDINO BENZOYLOXY PHENYLACETIC ACID METHANESULFONATE) among observed blood concentrations at time points Immediately before administration of IP After administration | 0-6 hr |