HealthyPhase 1NCT04064073
Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)
A Phase 1 study testing DWP16001, Metformin IR and DWP16001+Metformin IR 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 drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DWP16001, Metformin IR and DWP16001+Metformin IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Aug 2019to 20 Nov 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults aged 19 to 50 years at the time of screening test
- 55.0 kg ≤ Body weight ≤ 90.0 kg and 18.0 ≤ Body Mass Index (BMI) ≤ 27.0
- Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
- Eligible to participate in the study at the discretion of the investigator by physical examination, laboratory test, and history taking, etc.
Who cannot join
- Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
- Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
- Hypersensitivity or medical history of clinically significant hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin, Metformin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.)
- Clinical laboratory test values are outside the accepted normal range at screening
- Other exclusive inclusion criteria, as defined in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Single / Multiple Dose, Crossover Phase 1, Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults
The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.
- Conditions
- Healthy
- Being tested
- DWP16001, Metformin IR, DWP16001+Metformin IR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP16001Drug
Tablets, Oral, once daily single dose
Metformin IRDrug
Metformin IR 1000mg, Tablets, Oral, BID for 7 days
DWP16001+Metformin IRDrug
Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: DWP16001 |
| 2 | Experimental | Not described Receives: Drug: Metformin IR |
| 3 | Experimental | Not described Receives: Drug: DWP16001+Metformin IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of DWP16001
Peak Plasma Concetration
Measured: 0-72 hours
AUClast of DWP16001
Area under the plasma concentration versus time curve
Measured: 0-72 hours
Cmax,ss of Metformin
Peak Plasma Concetration at steady-state
Measured: 0-144 hours
AUCτ,ss of Metformin
Area under the plasma concentration versus time curve at Tau, steady-state
Measured: 0-144 hours
Secondary outcomes (6)
Tmax of DWP 16001, Metformin, DWP16001 Metabolites
Time at Cmax
Measured: 0-144 hours
AUC of DWP 16001, Metformin, DWP16001 Metabolites
Area under the plasma concentration versus time curve
Measured: 0-144 hours
T1/2 of DWP 16001, Metformin
Measured: 0-144 hours
CL/F of DWP 16001, Metformin
Apparent total clearance of the drug from plasma after oral administration
Measured: 0-144 hours
fe of DWP 16001, DWP16001 Metabolites
Fraction of the drug excreted into the urine
Measured: 0-72 hours
CLR of DWP 16001
Renal clearance of the drug from plasma
Measured: 0-144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start14 Aug 2019
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
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
- 34 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
- NCT04064073
- Sponsor's protocol ID
- DW_DWP16001102
- Status last verified
- Jan 2020
- First submitted
- 2 Aug 2019
- Last updated
- 13 Jan 2020
- 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single / Multiple Dose, Crossover Phase 1, Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT04064073
- Acronym / sponsor ID
- DW_DWP16001102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 21 Aug 2019 (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 drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DWP16001 |
| 2 | Experimental | Drug: Metformin IR |
| 3 | Experimental | Drug: DWP16001+Metformin IR |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male adults aged 19 to 50 years at the time of screening test
- 55.0 kg ≤ Body weight ≤ 90.0 kg and 18.0 ≤ Body Mass Index (BMI) ≤ 27.0
- Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
- Eligible to participate in the study at the discretion of the investigator by physical examination, laboratory test, and history taking, etc.
Key exclusion criteria (5 listed)
- Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
- Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
- Hypersensitivity or medical history of clinically significant hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin, Metformin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.)
- Clinical laboratory test values are outside the accepted normal range at screening
- Other exclusive inclusion criteria, as defined in the protocol
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 |
|---|---|---|
| DWP16001Tablets, Oral, once daily single dose | Drug | 1 |
| Metformin IRMetformin IR 1000mg, Tablets, Oral, BID for 7 days | Drug | 2 |
| DWP16001+Metformin IRTablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg | Drug | 3 |
Primary outcome
Cmax of DWP16001
Time frame: 0-72 hours
Peak Plasma Concetration
AUClast of DWP16001
Time frame: 0-72 hours
Area under the plasma concentration versus time curve
Cmax,ss of Metformin
Time frame: 0-144 hours
Peak Plasma Concetration at steady-state
AUCτ,ss of Metformin
Time frame: 0-144 hours
Area under the plasma concentration versus time curve at Tau, steady-state
6 secondary outcomes
Tmax of DWP 16001, Metformin, DWP16001 Metabolites
Time frame: 0-144 hours
AUC of DWP 16001, Metformin, DWP16001 Metabolites
Time frame: 0-144 hours
T1/2 of DWP 16001, Metformin
Time frame: 0-144 hours
CL/F of DWP 16001, Metformin
Time frame: 0-144 hours
fe of DWP 16001, DWP16001 Metabolites
Time frame: 0-72 hours
CLR of DWP 16001
Time frame: 0-144 hours
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 13 Jan 2020.
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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 DWP16001, Metformin IR and DWP16001+Metformin IR 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 4 inclusion and 5 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 13 Jan 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 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 DWP16001 (time frame: 0-72 hours). The study lists 4 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 13 Jan 2020.