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

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04782505

Collaborator

(none)

Enrollment

Location

Arms

1.8

Anticipated Duration (Months)

30.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: DWJ1248	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Part1. Parallel, Part2. CrossoverPart1. Parallel, Part2. Crossover

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 13, 2021

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

May 7, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungnam National University Hospital	Daejeon		Korea, Republic of	35015

Sponsors and Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT04782505

Other Study ID Numbers:

DW_DWJ1248101

First Posted:

Mar 4, 2021

Last Update Posted:

Mar 4, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 4, 2021