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

NCT ID: NCT04782505

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-12
• Study Completion Date: 2021-06-28

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 (Part 1)

DWJ1248 100mg (100mg 1tab) PO

Group Type: EXPERIMENTAL

DWJ1248

Intervention Type: DRUG

Camostat mesylate Tablet from Daewoong

Cohort 2 (Part 1)

DWJ1248 200mg (100mg 2tab) PO

Group Type: EXPERIMENTAL

DWJ1248

Intervention Type: DRUG

Camostat mesylate Tablet from Daewoong

Cohort 3 (Part 1)

DWJ1248 300mg (100mg 3tab) PO

Group Type: EXPERIMENTAL

DWJ1248

Intervention Type: DRUG

Camostat mesylate Tablet from Daewoong

Group A (Part 2)

DWJ1248 100mg 2tab PO - Wash out - DWJ1248 200mg 1tab PO

Group Type: EXPERIMENTAL

DWJ1248

Intervention Type: DRUG

Camostat mesylate Tablet from Daewoong

Group B (Part 2)

DWJ1248 200mg 1tab PO - Wash out - DWJ1248 100mg 2tab PO

Group Type: EXPERIMENTAL

DWJ1248

Intervention Type: DRUG

Camostat mesylate Tablet from Daewoong

Interventions

DWJ1248

Camostat mesylate Tablet from Daewoong

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chungnam National University Hospital

Daejeon, , South Korea

Countries

South Korea

Other Identifiers

DW_DWJ1248101

Identifier Type: -

Identifier Source: org_study_id