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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DWJ1248

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): March 16, 2021
• Study Completion (Actual): June 28, 2021

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWJ1248101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No