HealthyPhase 1NCT02757144
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers
A Phase 1 study testing DWP14012 and Esomeprazole 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 DWP14012 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?
- DWP14012 and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Feb 2017
- 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 adult males aged between 19 and 50 at screening
- Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Who cannot join
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- Those who have been Helicobacter pylori positive
- Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- Those who have anatomical disability in insertion and maintenance of pH meter catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 DWP14012 After 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 DWP14012 after oral administration in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- DWP14012, Placebo, Esomeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012Drug
DWP14012 tablets
PlaceboDrug
DWP14012 placebo-matching tablets, Active control placebo-matching tablets
EsomeprazoleDrug
Nexium®
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: DWP14012 Amg | Experimental | DWP14012 Amg, tablets, orally, single dose administration Receives: Drug: DWP14012; Drug: Placebo |
| Cohort 2: DWP14012 Bmg | Experimental | DWP14012 Bmg, tablets, orally, single dose administration Receives: Drug: DWP14012; Drug: Placebo |
| Cohort 3: DWP14012 Cmg | Experimental | DWP14012 Cmg, tablets, orally, single dose administration Receives: Drug: DWP14012; Drug: Placebo |
| Cohort 4: DWP14012 Dmg | Experimental | DWP14012 Dmg, tablets, orally, single dose administration Receives: Drug: DWP14012; Drug: Placebo |
| Cohort 5: DWP14012 Emg | Experimental | DWP14012 Emg, tablets, orally, single dose administration Receives: Drug: DWP14012; Drug: Placebo |
| Cohort 6: DWP14012 Fmg | Experimental | DWP14012 Emg, tablets, orally, single dose administration Receives: Drug: DWP14012; Drug: Placebo |
| Cohort 1-6: Placebo | Placebo comparator | DWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, single dose administration Receives: Drug: Placebo |
| Cohort 1-6: Esomeprazole | Active comparator | Nexium® tablets, orally, single dose administration Receives: Drug: Placebo; Drug: Esomeprazole |
| Cohort 7: DWP14012 Amg | Experimental | DWP14012 Amg, tablets, orally, repeated dose administration(for 7days) Receives: Drug: DWP14012; Drug: Placebo |
| Cohort 8: DWP14012 Bmg | Experimental | DWP14012 Bmg, tablets, orally, repeated dose administration(for 7days) Receives: Drug: DWP14012; Drug: Placebo |
| Cohort 9: DWP14012 Cmg | Experimental | DWP14012 Cmg, tablets, orally, repeated dose administration(for 7days) Receives: Drug: DWP14012; Drug: Placebo |
| Cohort 7-10: Placebo | Placebo comparator | DWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 7days) Receives: Drug: Placebo |
| Cohort 7-10: Esomeprazole | Active comparator | Nexium®, orally, repeated dose administration(for 7days) Receives: Drug: Placebo; Drug: Esomeprazole |
| Cohort 9: DWP14012 Dmg | Experimental | DWP14012 Dmg, tablets, orally, repeated dose administration(for 7days) Receives: Drug: DWP14012; Drug: Placebo |
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 adn severe.
Measured: Day -2(Randomization) to Day 11~18(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 11~18(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 11~18(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 11~18(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 11~18(Post-study visit)
Secondary outcomes (13)
Cmax: Maximum concentration of DWP14012
in single ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
Cmax,ss: Maximum concentration of DWP14012 at steady state
in multiple ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
Cmin,ss: Minimum concentration of DWP14012 at steady state
in multiple ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
Tmax: Time of maximum concentration
in single ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
Tmax,ss: Time of maximum concentration at steady state
in multiple ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
AUClast: Area under the plasma concentration-time curve from time 0 to 48hours
in single ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
AUCinf: Area under the plasma concentration-time curve from time 0 to infinity
in single ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
AUCtau: Area under the plasma concentration-time curve from time 0 to tau(dosing interval)
in multiple ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
T1/2: Elimination half-life
in single ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
T1/2: Elimination half-life
in multiple ascending dose cohort
Measured: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
Percentage of total time that the intragastric pH was above 4
After single administration of the investigational products, 24hr gastric pH monitoring started.
Measured: Day 1
Percentage of total time that the intragastric pH was above 4
After multiple administration of the investigational products, 24hr gastric pH monitoring started.
Measured: Day 7
Serum gastrin concentration profile
Measured: Day -2(Randomization) to Day 11~18(Post-study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
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
- NCT02757144
- Sponsor's protocol ID
- DW_DWP14012001
- Status last verified
- Apr 2017
- First submitted
- 16 Mar 2016
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 DWP14012 After Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02757144
- Acronym / sponsor ID
- DW_DWP14012001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 29 Apr 2016 (estimated)
- 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 DWP14012 after oral administration in healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: DWP14012 Amg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Amg, tablets, orally, single dose administration |
| Cohort 2: DWP14012 Bmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Bmg, tablets, orally, single dose administration |
| Cohort 3: DWP14012 Cmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Cmg, tablets, orally, single dose administration |
| Cohort 4: DWP14012 Dmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Dmg, tablets, orally, single dose administration |
| Cohort 5: DWP14012 Emg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Emg, tablets, orally, single dose administration |
| Cohort 6: DWP14012 Fmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Emg, tablets, orally, single dose administration |
| Cohort 1-6: Placebo | Placebo comparator | Drug: PlaceboDWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, single dose administration |
| Cohort 1-6: Esomeprazole | Active comparator | Drug: Placebo, Drug: EsomeprazoleNexium® tablets, orally, single dose administration |
| Cohort 7: DWP14012 Amg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Amg, tablets, orally, repeated dose administration(for 7days) |
| Cohort 8: DWP14012 Bmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Bmg, tablets, orally, repeated dose administration(for 7days) |
| Cohort 9: DWP14012 Cmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Cmg, tablets, orally, repeated dose administration(for 7days) |
| Cohort 7-10: Placebo | Placebo comparator | Drug: PlaceboDWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 7days) |
| Cohort 7-10: Esomeprazole | Active comparator | Drug: Placebo, Drug: EsomeprazoleNexium®, orally, repeated dose administration(for 7days) |
| Cohort 9: DWP14012 Dmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Dmg, tablets, orally, repeated dose administration(for 7days) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult males aged between 19 and 50 at screening
- Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Key exclusion criteria (5 listed)
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- Those who have been Helicobacter pylori positive
- Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- Those who have anatomical disability in insertion and maintenance of pH meter catheter
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 |
|---|---|---|
| DWP14012DWP14012 tablets | Drug | Cohort 1: DWP14012 Amg, Cohort 2: DWP14012 Bmg, Cohort 3: DWP14012 Cmg, Cohort 4: DWP14012 Dmg, Cohort 5: DWP14012 Emg, Cohort 6: DWP14012 Fmg, Cohort 7: DWP14012 Amg, Cohort 8: DWP14012 Bmg, Cohort 9: DWP14012 Cmg, Cohort 9: DWP14012 Dmg |
| PlaceboDWP14012 placebo-matching tablets, Active control placebo-matching tablets | Drug | Cohort 1-6: Esomeprazole, Cohort 1-6: Placebo, Cohort 1: DWP14012 Amg, Cohort 2: DWP14012 Bmg, Cohort 3: DWP14012 Cmg, Cohort 4: DWP14012 Dmg, Cohort 5: DWP14012 Emg, Cohort 6: DWP14012 Fmg, Cohort 7-10: Esomeprazole, Cohort 7-10: Placebo, Cohort 7: DWP14012 Amg, Cohort 8: DWP14012 Bmg, Cohort 9: DWP14012 Cmg, Cohort 9: DWP14012 Dmg |
| EsomeprazoleNexium® | Drug | Cohort 1-6: Esomeprazole, Cohort 7-10: Esomeprazole |
Primary outcome
Number and percentage of Participants With Adverse Events (AE)
Time frame: Day -2(Randomization) to Day 11~18(Post-study visit)
All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate adn severe.
Number and percentage of Participants With Adverse Drug Reactions (ADR)
Time frame: Day -2(Randomization) to Day 11~18(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 11~18(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 11~18(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 11~18(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.
13 secondary outcomes
Cmax: Maximum concentration of DWP14012
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
Cmax,ss: Maximum concentration of DWP14012 at steady state
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
Cmin,ss: Minimum concentration of DWP14012 at steady state
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
Tmax: Time of maximum concentration
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
Tmax,ss: Time of maximum concentration at steady state
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
AUClast: Area under the plasma concentration-time curve from time 0 to 48hours
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
AUCinf: Area under the plasma concentration-time curve from time 0 to infinity
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
AUCtau: Area under the plasma concentration-time curve from time 0 to tau(dosing interval)
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
T1/2: Elimination half-life
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
T1/2: Elimination half-life
Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours
Percentage of total time that the intragastric pH was above 4
Time frame: Day 1
Percentage of total time that the intragastric pH was above 4
Time frame: Day 7
Serum gastrin concentration profile
Time frame: Day -2(Randomization) to Day 11~18(Post-study visit)
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 25 Apr 2017.
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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 DWP14012 and Esomeprazole 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 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 25 Apr 2017. 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. Some participants in this study may receive a placebo. 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 11~18(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 25 Apr 2017.