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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DWJ1248

Study type: Interventional

Funder types: Industry

Identifiers

NCT04782505

DW_DWJ1248101

Details and patient eligibility

About

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

Enrollment: 61 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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61 participants in 5 patient groups

Cohort 1 (Part 1)

Experimental group

Description:

DWJ1248 100mg (100mg 1tab) PO

Treatment:

Drug: DWJ1248

Cohort 2 (Part 1)

Experimental group

Description:

DWJ1248 200mg (100mg 2tab) PO

Treatment:

Drug: DWJ1248

Cohort 3 (Part 1)

Experimental group

Description:

DWJ1248 300mg (100mg 3tab) PO

Treatment:

Drug: DWJ1248

Group A (Part 2)

Experimental group

Description:

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

Treatment:

Drug: DWJ1248

Group B (Part 2)

Experimental group

Description:

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

Treatment:

Drug: DWJ1248