HealthyPhase 1NCT04393597
Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults
A Phase 1 study testing DWJ1458 (fasted) and DWJ1458 (fed) in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration 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?
- DWJ1458 (fasted) and DWJ1458 (fed)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 May 2020to 30 Nov 2020
- 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
- Age 19 to 55 years
- BMI 18.5≥ and ≤27.0 kg/m²
- Female subjects must be menopause or surgically infertility.
- Male subjects must consent to contraception for at least 60 days after the study period and the final administration of the study drug.
- Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.
Who cannot join
- History of hypersensitivity to investigational product
- Participation in a clinical drug study or bioequivalence study 6 months prior to the present study
- The subject who is judged to be unsuitable as a test subject in a screening test.
- The subject who is judged to be unsuitable for participation in a clinical trial due to other reasons determined by the investigators.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics of Orally Administered DWJ1458 in Healthy Adults
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.
Read the detailed description
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study
- Conditions
- Healthy
- Being tested
- DWJ1458 (fasted), DWJ1458 (fed)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1458 (fasted)Drug
Subjects take single dose of DWJ1458 on a fated condition
DWJ1458 (fed)Drug
Subjects take single dose of DWJ1458 after high-fat diet
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet. Receives: Drug: DWJ1458 (fasted); Drug: DWJ1458 (fed) |
| Group 2 | Experimental | Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition. Receives: Drug: DWJ1458 (fasted); Drug: DWJ1458 (fed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter of DWJ1458: AUC0-t
Area under the plasma concentration-time curve from time 0 to time t
Measured: 0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: Cmax
Maximum plasma drug concentration
Measured: 0 - 144 hours after dosing
Secondary outcomes (5)
Pharmacokinetic parameter of DWJ1458: AUCinf
Area under the plasma concentration-time curve from drug administration to drug elimination
Measured: 0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: Tmax
Time to reach maximum plasma concentration following drug administration
Measured: 0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: t1/2
Elimination half-life
Measured: 0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: Vd/F
Apparent volume of distribution after oral administration
Measured: 0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: Cl/F
Apparent total clearance of drug from plasma after oral administration
Measured: 0 - 144 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start28 May 2020 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Why it stopped: We decided to discontinue this particular clinical study through internal discussion.
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
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT04393597
- Sponsor's protocol ID
- DW_DWJ1458102
- Status last verified
- Jun 2020
- First submitted
- 13 May 2020
- Last updated
- 12 Jun 2020
- 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 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics of Orally Administered DWJ1458 in Healthy Adults
- ClinicalTrials.gov ID
- NCT04393597
- Acronym / sponsor ID
- DW_DWJ1458102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We decided to discontinue this particular clinical study through internal discussion.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 28 May 2020 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 19 May 2020 (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.
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.
Detailed description
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: DWJ1458 (fasted), Drug: DWJ1458 (fed)Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet. |
| Group 2 | Experimental | Drug: DWJ1458 (fasted), Drug: DWJ1458 (fed)Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 19 to 55 years
- BMI 18.5≥ and ≤27.0 kg/m²
- Female subjects must be menopause or surgically infertility.
- Male subjects must consent to contraception for at least 60 days after the study period and the final administration of the study drug.
- Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.
Key exclusion criteria (4 listed)
- History of hypersensitivity to investigational product
- Participation in a clinical drug study or bioequivalence study 6 months prior to the present study
- The subject who is judged to be unsuitable as a test subject in a screening test.
- The subject who is judged to be unsuitable for participation in a clinical trial due to other reasons determined by the investigators.
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 |
|---|---|---|
| DWJ1458 (fasted)Subjects take single dose of DWJ1458 on a fated condition | Drug | Group 1, Group 2 |
| DWJ1458 (fed)Subjects take single dose of DWJ1458 after high-fat diet | Drug | Group 1, Group 2 |
Primary outcome
Pharmacokinetic parameter of DWJ1458: AUC0-t
Time frame: 0 - 144 hours after dosing
Area under the plasma concentration-time curve from time 0 to time t
Pharmacokinetic parameter of DWJ1458: Cmax
Time frame: 0 - 144 hours after dosing
Maximum plasma drug concentration
5 secondary outcomes
Pharmacokinetic parameter of DWJ1458: AUCinf
Time frame: 0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: Tmax
Time frame: 0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: t1/2
Time frame: 0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: Vd/F
Time frame: 0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: Cl/F
Time frame: 0 - 144 hours after dosing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- 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 DWJ1458 (fasted) and DWJ1458 (fed) 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Jun 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetic parameter of DWJ1458: AUC0-t (time frame: 0 - 144 hours after dosing). 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 12 Jun 2020.