HealthyPhase 1NCT03364985
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers
A Phase 1 study testing DWP16001 and Dapagliflozin in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP16001 after oral administration in healthy male volunteers. 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 and Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Dec 2017to 30 Jul 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 at the time of screening test.
- Body weight between 50.0 kg and 90.0 kg and Body Mass Index (BMI) between 18.0 and 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 by discretion of the investigator following medical examination by interview, physical examination, and clinical examination.
Who cannot join
- Presence of a clinically significant hepatic, renal, nervous, respiratory, endocrine, blood•tumor, cardiovascular, urogenital, psychiatric disorder or prior history.
- Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of surgery (except for simple appendectomy or hernia surgery) that may affect safety and PK/PD assessment.
- Hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.) or medical history of clinically significant hypersensitivity.
- Following laboratory abnormalities identified during the screening test:
- AST (SGOT), ALT (SGPT) >1.5 upper limit of normal range
- Creatinine clearance calculated by the MDRD equation < 90 mL/min
Show all 9Show fewer
- Repeatedly confirmed QTc interval > 450 ms
- Fasting serum glucose > 110mg/dL or < 70mg/dL
- Serum HbA1c > 6.5 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo- and Active-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of DWP16001 Following Oral Administration in Healthy Male Volunteers
This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP16001 after oral administration in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- DWP16001, Placebo, Dapagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP16001Drug
DWP16001 tablets
PlaceboDrug
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
DapagliflozinDrug
Forxiga®
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: DWP16001 Amg | Experimental | DWP16001 Amg, tablets, orally, single dose administration Receives: Drug: DWP16001; Drug: Placebo; Drug: Dapagliflozin |
| Cohort 2: DWP16001 Bmg | Experimental | DWP16001 Bmg, tablets, orally, single dose administration Receives: Drug: DWP16001; Drug: Placebo; Drug: Dapagliflozin |
| Cohort 3: DWP16001 Cmg | Experimental | DWP16001 Cmg, tablets, orally, single dose administration Receives: Drug: DWP16001; Drug: Placebo; Drug: Dapagliflozin |
| Cohort 4: DWP16001 Dmg | Experimental | DWP16001 Dmg, tablets, orally, single dose administration Receives: Drug: DWP16001; Drug: Placebo; Drug: Dapagliflozin |
| Cohort 5: DWP16001 Emg | Experimental | DWP16001 Emg, tablets, orally, single dose administration Receives: Drug: DWP16001; Drug: Placebo; Drug: Dapagliflozin |
| Cohort 6: DWP16001 Fmg | Experimental | DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days) Receives: Drug: DWP16001; Drug: Placebo; Drug: Dapagliflozin |
| Cohort 7: DWP16001 Gmg | Experimental | DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days) Receives: Drug: DWP16001; Drug: Placebo; Drug: Dapagliflozin |
| Cohort 8: DWP16001 Hmg | Experimental | DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days) Receives: Drug: DWP16001; Drug: Placebo; Drug: Dapagliflozin |
| Cohort 9: DWP16001 Img | Experimental | DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days) Receives: Drug: DWP16001; Drug: Placebo; Drug: Dapagliflozin |
| Cohort 10: DWP16001 Jmg | Experimental | DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days) Receives: Drug: DWP16001; Drug: Placebo; Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of Participants With Adverse Events (AE)
All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate and severe
Measured: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)
Number and percentage of Participants With Adverse Drug Reactions (ADR)
An adverse drug reaction (ADR) is an injury caused by taking an investigational product
Measured: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)
Number of Participants With Clinically Significant Vital Sign findings
Blood pressure, pulse and body temperature were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability
Measured: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)
Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings
Ventricular rate, RR interval, PR interval, QRS duration, QTcB and QTcF were recorded. The results of 12-lead ECG will be categorized Normal/Abnormal NCS(No clinically significant)/Abnormal CS(clinically significant).
Measured: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)
Number of Participants With Clinically Significant Laboratory results
Hematology, Blood chemistry, Coagulation and Urinalysis were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability.
Measured: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)
Secondary outcomes (17)
Cmax: Maximum concentration of DWP16001
in single ascending dose cohort
Measured: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour
Cmax,ss: Maximum concentration of DWP16001 at steady state
in multiple ascending dose cohort
Measured: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Cmin,ss: Minimum concentration of DWP16001 at steady state
in multiple ascending dose cohort
Measured: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Time of maximum concentration
in single ascending dose cohort
Measured: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour
Tmax,ss: Time of maximum concentration at steady state
in multiple ascending dose cohort
Measured: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
AUClast: Area under the plasma concentration-time curve from time 0 to 72hours
in single ascending dose cohort
Measured: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour
AUCinf: Area under the plasma concentration-time curve from time 0 to infinity
in single ascending dose cohort
Measured: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour
AUCtau: Area under the plasma concentration-time curve from time 0 to tau(dosing interval)
in multiple ascending dose cohort
Measured: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
T1/2: Elimination half-life
in single ascending dose cohort
Measured: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour
T1/2: Elimination half-life
in multiple ascending dose cohort
Measured: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
concentration of serum glucose
in single ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
concentration of serum glucose
in multiple ascending dose cohort
Measured: Day 1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 pre dose, Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
concentration of insulin
in multiple ascending dose cohort
Measured: Day -1 pre dose, 0.5, 1, 1.5, 2, 3, 4 hour, Day 15 pre dose, 0.5, 1, 1.5, 2, 3, 4 hour
Changes from baseline for Body weight in kilograms
in multiple ascending dose cohort
Measured: Day -1 0 hour, Day 15 0 hour
Changes from baseline for HbA1C in percent
in multiple ascending dose cohort
Measured: Day -1 0 hour, Day 15 0 hour
concentration of Urine glucose excretion
in single ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
concentration of Urine glucose excretion
in multiple ascending dose cohort
Measured: Day 1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 pre dose, Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start3 Dec 2017
- Primary completion21 May 2019
- Study completion30 Jul 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 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
- NCT03364985
- Sponsor's protocol ID
- DW_DWP16001001
- Status last verified
- Aug 2019
- First submitted
- 29 Nov 2017
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo- and Active-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of DWP16001 Following Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03364985
- Acronym / sponsor ID
- DW_DWP16001001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2017 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 7 Dec 2017 (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.
This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP16001 after oral administration in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: DWP16001 Amg | Experimental | Drug: DWP16001, Drug: Placebo, Drug: DapagliflozinDWP16001 Amg, tablets, orally, single dose administration |
| Cohort 2: DWP16001 Bmg | Experimental | Drug: DWP16001, Drug: Placebo, Drug: DapagliflozinDWP16001 Bmg, tablets, orally, single dose administration |
| Cohort 3: DWP16001 Cmg | Experimental | Drug: DWP16001, Drug: Placebo, Drug: DapagliflozinDWP16001 Cmg, tablets, orally, single dose administration |
| Cohort 4: DWP16001 Dmg | Experimental | Drug: DWP16001, Drug: Placebo, Drug: DapagliflozinDWP16001 Dmg, tablets, orally, single dose administration |
| Cohort 5: DWP16001 Emg | Experimental | Drug: DWP16001, Drug: Placebo, Drug: DapagliflozinDWP16001 Emg, tablets, orally, single dose administration |
| Cohort 6: DWP16001 Fmg | Experimental | Drug: DWP16001, Drug: Placebo, Drug: DapagliflozinDWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days) |
| Cohort 7: DWP16001 Gmg | Experimental | Drug: DWP16001, Drug: Placebo, Drug: DapagliflozinDWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days) |
| Cohort 8: DWP16001 Hmg | Experimental | Drug: DWP16001, Drug: Placebo, Drug: DapagliflozinDWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days) |
| Cohort 9: DWP16001 Img | Experimental | Drug: DWP16001, Drug: Placebo, Drug: DapagliflozinDWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days) |
| Cohort 10: DWP16001 Jmg | Experimental | Drug: DWP16001, Drug: Placebo, Drug: DapagliflozinDWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days) |
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 at the time of screening test.
- Body weight between 50.0 kg and 90.0 kg and Body Mass Index (BMI) between 18.0 and 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 by discretion of the investigator following medical examination by interview, physical examination, and clinical examination.
Key exclusion criteria (9 listed)
- Presence of a clinically significant hepatic, renal, nervous, respiratory, endocrine, blood•tumor, cardiovascular, urogenital, psychiatric disorder or prior history.
- Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of surgery (except for simple appendectomy or hernia surgery) that may affect safety and PK/PD assessment.
- Hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.) or medical history of clinically significant hypersensitivity.
- Following laboratory abnormalities identified during the screening test:
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 |
|---|---|---|
| DWP16001DWP16001 tablets | Drug | Cohort 10: DWP16001 Jmg, Cohort 1: DWP16001 Amg, Cohort 2: DWP16001 Bmg, Cohort 3: DWP16001 Cmg, Cohort 4: DWP16001 Dmg, Cohort 5: DWP16001 Emg, Cohort 6: DWP16001 Fmg, Cohort 7: DWP16001 Gmg, Cohort 8: DWP16001 Hmg, Cohort 9: DWP16001 Img |
| PlaceboDWP16001 placebo-matching tablets, Active control placebo-matching tablets | Drug | Cohort 10: DWP16001 Jmg, Cohort 1: DWP16001 Amg, Cohort 2: DWP16001 Bmg, Cohort 3: DWP16001 Cmg, Cohort 4: DWP16001 Dmg, Cohort 5: DWP16001 Emg, Cohort 6: DWP16001 Fmg, Cohort 7: DWP16001 Gmg, Cohort 8: DWP16001 Hmg, Cohort 9: DWP16001 Img |
| DapagliflozinForxiga® | Drug | Cohort 10: DWP16001 Jmg, Cohort 1: DWP16001 Amg, Cohort 2: DWP16001 Bmg, Cohort 3: DWP16001 Cmg, Cohort 4: DWP16001 Dmg, Cohort 5: DWP16001 Emg, Cohort 6: DWP16001 Fmg, Cohort 7: DWP16001 Gmg, Cohort 8: DWP16001 Hmg, Cohort 9: DWP16001 Img |
Primary outcome
Number and percentage of Participants With Adverse Events (AE)
Time frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)
All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate and severe
Number and percentage of Participants With Adverse Drug Reactions (ADR)
Time frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)
An adverse drug reaction (ADR) is an injury caused by taking an investigational product
Number of Participants With Clinically Significant Vital Sign findings
Time frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)
Blood pressure, pulse and body temperature were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability
Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings
Time frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)
Ventricular rate, RR interval, PR interval, QRS duration, QTcB and QTcF were recorded. The results of 12-lead ECG will be categorized Normal/Abnormal NCS(No clinically significant)/Abnormal CS(clinically significant).
Number of Participants With Clinically Significant Laboratory results
Time frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)
Hematology, Blood chemistry, Coagulation and Urinalysis were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability.
17 secondary outcomes
Cmax: Maximum concentration of DWP16001
Time frame: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour
Cmax,ss: Maximum concentration of DWP16001 at steady state
Time frame: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Cmin,ss: Minimum concentration of DWP16001 at steady state
Time frame: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
Time of maximum concentration
Time frame: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour
Tmax,ss: Time of maximum concentration at steady state
Time frame: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
AUClast: Area under the plasma concentration-time curve from time 0 to 72hours
Time frame: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour
AUCinf: Area under the plasma concentration-time curve from time 0 to infinity
Time frame: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour
AUCtau: Area under the plasma concentration-time curve from time 0 to tau(dosing interval)
Time frame: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
T1/2: Elimination half-life
Time frame: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour
T1/2: Elimination half-life
Time frame: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
concentration of serum glucose
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
concentration of serum glucose
Time frame: Day 1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 pre dose, Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
concentration of insulin
Time frame: Day -1 pre dose, 0.5, 1, 1.5, 2, 3, 4 hour, Day 15 pre dose, 0.5, 1, 1.5, 2, 3, 4 hour
Changes from baseline for Body weight in kilograms
Time frame: Day -1 0 hour, Day 15 0 hour
Changes from baseline for HbA1C in percent
Time frame: Day -1 0 hour, Day 15 0 hour
concentration of Urine glucose excretion
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
concentration of Urine glucose excretion
Time frame: Day 1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 pre dose, Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour
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 21 Aug 2019.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 and Dapagliflozin 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 9 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 21 Aug 2019. 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?
Number and percentage of Participants With Adverse Events (AE) (time frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)). The study lists 5 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 21 Aug 2019.