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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DWJ1248

• Registration Number: NCT04782505
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy volunteers

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2021-03-12
• Primary Completion: 2021-03-16
• Study Completion: 2021-06-28
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1 (Part 1)	DWJ1248	DWJ1248 100mg (100mg 1tab) PO
Cohort 2 (Part 1)	DWJ1248	DWJ1248 200mg (100mg 2tab) PO
Cohort 3 (Part 1)	DWJ1248	DWJ1248 300mg (100mg 3tab) PO
Group B (Part 2)	DWJ1248	DWJ1248 200mg 1tab PO - Wash out - DWJ1248 100mg 2tab PO
Group A (Part 2)	DWJ1248	DWJ1248 100mg 2tab PO - Wash out - DWJ1248 200mg 1tab PO

Primary Outcome Measures

Name	Time	Method
Cmax of GBPA	0-6 hr	Maximum blood concentration of GBPA (GUANIDINO BENZOYLOXY PHENYLACETIC ACID METHANESULFONATE) among observed blood concentrations at time points; * Immediately before administration of IP; * After administration
AUClast of GBPA	0-6 hr	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

Trial Locations

Locations (1)

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of