Drug-drug InteractionPhase 1NCT04328766
Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers
A Phase 1 study testing DWC202005, alone, DWP14012 + DWC202005 and DWP14012 + DWC202005, after multiple doses of DWP14012 in people with Drug-drug Interaction, run by Daewoong Pharmaceutical Co. LTD. at 1 site in Australia.
Trial summary
An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction
- What is being tested?
- DWC202005, alone, DWP14012 + DWC202005 and DWP14012 + DWC202005, after multiple doses of DWP14012
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Sep 2020to 21 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2
- Capable of understanding provided information and complying with protocol requirements
- Provide written informed consent to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Multiple-Dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers
An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers
- Conditions
- Drug-drug Interaction
- Being tested
- DWC202005, alone, DWP14012 + DWC202005, DWP14012 + DWC202005, after multiple doses of DWP14012
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWC202005, aloneDrug
DWC202005, as a single dose
DWP14012 + DWC202005Drug
DWP14012 and DWC202005, as a single dose
DWP14012 + DWC202005, after multiple doses of DWP14012Drug
DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days
| Study group | Role | What they receive |
|---|---|---|
| DWP14012 Cohort A | Experimental | Not described Receives: Drug: DWC202005, alone |
| DWP14012 Cohort B | Experimental | Not described Receives: Drug: DWP14012 + DWC202005 |
| DWP14012 Cohort C | Experimental | Not described Receives: Drug: DWP14012 + DWC202005, after multiple doses of DWP14012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration-time curve
AUClast of DWC202005
Measured: upto 48 hours postdose
Peak Plasma Concentration (Cmax)
Cmax of DWC202005
Measured: upto 48 hours postdose
Incidence of Treatment-Emergent Adverse Events
Measured: up to 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start6 Sep 2020
- Primary completion21 Nov 2020
- Study completion21 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-drug InteractionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT04328766
- Sponsor's protocol ID
- DW_DWP14012106
- Status last verified
- Aug 2021
- First submitted
- 24 Mar 2020
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multiple-Dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04328766
- Acronym / sponsor ID
- DW_DWP14012106
- Conditions
- Drug-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2020 (actual)
- Primary completion
- 21 Nov 2020 (actual)
- Study completion
- 21 Nov 2020 (actual)
- First posted
- 31 Mar 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.
An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DWP14012 Cohort A | Experimental | Drug: DWC202005, alone |
| DWP14012 Cohort B | Experimental | Drug: DWP14012 + DWC202005 |
| DWP14012 Cohort C | Experimental | Drug: DWP14012 + DWC202005, after multiple doses of DWP14012 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2
- Capable of understanding provided information and complying with protocol requirements
- Provide written informed consent to participate in the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DWC202005, aloneDWC202005, as a single dose | Drug | DWP14012 Cohort A |
| DWP14012 + DWC202005DWP14012 and DWC202005, as a single dose | Drug | DWP14012 Cohort B |
| DWP14012 + DWC202005, after multiple doses of DWP14012DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days | Drug | DWP14012 Cohort C |
Primary outcome
Area under the plasma drug concentration-time curve
Time frame: upto 48 hours postdose
AUClast of DWC202005
Peak Plasma Concentration (Cmax)
Time frame: upto 48 hours postdose
Cmax of DWC202005
Incidence of Treatment-Emergent Adverse Events
Time frame: up to 19 days
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 16 Aug 2021.
Related trials for Drug-drug Interaction
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
RecruitingPhase 1
A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants
Healthy
Not yet recruitingPhase 1
LTG-321 - Itraconazole Drug-drug Interaction (DDI) Study
PK Drug-drug Interaction Study
Active, not recruitingPhase 1
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer
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 DWC202005, alone, DWP14012 + DWC202005 and DWP14012 + DWC202005, after multiple doses of DWP14012 in people with Drug-drug Interaction, run by Daewoong Pharmaceutical Co. LTD. at 1 site in Australia.
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 0 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 16 Aug 2021. 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 Australia. 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?
Area under the plasma drug concentration-time curve (time frame: upto 48 hours postdose). The study lists 3 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 16 Aug 2021.