HealthyPhase 1NCT04782505
Safety and Pharmacokinetics Evaluation Study According to the Dose of Camostat Mesylate in Healthy Volunteers
A Phase 1 study testing DWJ1248 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DWJ1248
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Mar 2021to 28 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy volunteers
- Conditions
- Healthy
- Being tested
- DWJ1248
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1248Drug
Camostat mesylate Tablet from Daewoong
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Part 1) | Experimental | DWJ1248 100mg (100mg 1tab) PO Receives: Drug: DWJ1248 |
| Cohort 2 (Part 1) | Experimental | DWJ1248 200mg (100mg 2tab) PO Receives: Drug: DWJ1248 |
| Cohort 3 (Part 1) | Experimental | DWJ1248 300mg (100mg 3tab) PO Receives: Drug: DWJ1248 |
| Group A (Part 2) | Experimental | DWJ1248 100mg 2tab PO - Wash out - DWJ1248 200mg 1tab PO Receives: Drug: DWJ1248 |
| Group B (Part 2) | Experimental | DWJ1248 200mg 1tab PO - Wash out - DWJ1248 100mg 2tab PO Receives: Drug: DWJ1248 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 0-6 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start12 Mar 2021
- Primary completion16 Mar 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Part1. Parallel, Part2. Crossover
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782505
- Sponsor's protocol ID
- DW_DWJ1248101
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04782505
- Acronym / sponsor ID
- DW_DWJ1248101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Part1. Parallel, Part2. Crossover
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Part 1) | Experimental | Drug: DWJ1248DWJ1248 100mg (100mg 1tab) PO |
| Cohort 2 (Part 1) | Experimental | Drug: DWJ1248DWJ1248 200mg (100mg 2tab) PO |
| Cohort 3 (Part 1) | Experimental | Drug: DWJ1248DWJ1248 300mg (100mg 3tab) PO |
| Group A (Part 2) | Experimental | Drug: DWJ1248DWJ1248 100mg 2tab PO - Wash out - DWJ1248 200mg 1tab PO |
| Group B (Part 2) | Experimental | Drug: DWJ1248DWJ1248 200mg 1tab PO - Wash out - DWJ1248 100mg 2tab PO |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWJ1248Camostat mesylate Tablet from Daewoong | Drug | Cohort 1 (Part 1), Cohort 2 (Part 1), Cohort 3 (Part 1), Group A (Part 2), Group B (Part 2) |
Primary outcome
Cmax of GBPA
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWJ1248 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of GBPA (time frame: 0-6 hr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.