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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782505
• Other study ID #: DW_DWJ1248101
• Status: Completed
• Phase: Phase 1
• Start date: March 12, 2021
• Est. completion date: June 28, 2021

Study information

• Verified date: March 2021
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 28, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DWJ1248
Camostat mesylate Tablet from Daewoong

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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