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
1 other identifier
interventional
61
1 country
1
Brief Summary
Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 4, 2021
CompletedStudy Start
First participant enrolled
March 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2021
CompletedDecember 5, 2022
March 1, 2021
4 days
March 1, 2021
December 2, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (5)
Cohort 1 (Part 1)
EXPERIMENTALDWJ1248 100mg (100mg 1tab) PO
Cohort 2 (Part 1)
EXPERIMENTALDWJ1248 200mg (100mg 2tab) PO
Cohort 3 (Part 1)
EXPERIMENTALDWJ1248 300mg (100mg 3tab) PO
Group A (Part 2)
EXPERIMENTALDWJ1248 100mg 2tab PO - Wash out - DWJ1248 200mg 1tab PO
Group B (Part 2)
EXPERIMENTALDWJ1248 200mg 1tab PO - Wash out - DWJ1248 100mg 2tab PO
Interventions
Camostat mesylate Tablet from Daewoong
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chungnam National University Hospital
Daejeon, 35015, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2021
First Posted
March 4, 2021
Study Start
March 12, 2021
Primary Completion
March 16, 2021
Study Completion
June 28, 2021
Last Updated
December 5, 2022
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share