HealthyPhase 1NCT03487562
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects
A Phase 1 study testing DWP14012 Amg, DWP14012 Bmg and Clarithromycin in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This is a randomized, open-label, multiple dose, two-part phase I clinical trial to compare the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after administrations of DWP14012 alone and combinations of DWP14012, Clarithromycin and Amoxicillin 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?
- DWP14012 Amg, DWP14012 Bmg and Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Apr 2018to 11 Jan 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 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
- Part I: Those who have been helicobacter pylori negative at screening Part II: Those who have been helicobacter pylori positive at screening
- 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 whose plasma AST (SGOT) and ALT (SGPT) exceed to the upper limit of the normal range
- 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 Randomized, Open-label, Multiple Dose, Two-part Phase I Clinical Trial to Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of DWP14012 After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects
This is a randomized, open-label, multiple dose, two-part phase I clinical trial to compare the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after administrations of DWP14012 alone and combinations of DWP14012, Clarithromycin and Amoxicillin in healthy male subjects
- Conditions
- Healthy
- Being tested
- DWP14012 Amg, DWP14012 Bmg, Clarithromycin, Amoxicillin, Lansoprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012 AmgDrug
DWP14012 Amg
DWP14012 BmgDrug
DWP14012 Bmg
ClarithromycinDrug
Clarithromycin 500 mg
AmoxicillinDrug
Amoxicillin 1 g
LansoprazoleDrug
Lansoprazole 30 mg
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Part I: A-B-D-C A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid Receives: Drug: DWP14012 Amg; Drug: Clarithromycin; Drug: Amoxicillin |
| Sequence 2 | Experimental | Part I: B-C-A-D A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid Receives: Drug: DWP14012 Amg; Drug: Clarithromycin; Drug: Amoxicillin |
| Sequence 3 | Experimental | Part I: C-D-B-A A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid Receives: Drug: DWP14012 Amg; Drug: Clarithromycin; Drug: Amoxicillin |
| Sequence 4 | Experimental | Part I: D-A-C-B A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid Receives: Drug: DWP14012 Amg; Drug: Clarithromycin; Drug: Amoxicillin |
| A | Experimental | Part II: (DWP14012 B mg + Clarithromycin 500 mg + Amoxicillin 1g) bid Receives: Drug: DWP14012 Bmg; Drug: Clarithromycin; Drug: Amoxicillin |
| B | Experimental | Part II: (DWP14012 A mg + Clarithromycin 500 mg + Amoxicillin 1g) bid Receives: Drug: DWP14012 Amg; Drug: Clarithromycin; Drug: Amoxicillin |
| C | Experimental | Part II: (Lansoprazole 30 mg + Clarithromycin 500 mg + Amoxicillin 1g) bid Receives: Drug: Clarithromycin; Drug: Amoxicillin; Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss: Maximum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state
Part I: each period (Group A, B, C, D) Part II: Group A, B
Measured: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Cmin,ss: Minimum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state
Part I: each period (Group A, B, C, D) Part II: Group A, B
Measured: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Cav,ss: Average concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state
Part I: each period (Group A, B, C, D) Part II: Group A, B
Measured: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
AUCt,ss: Area under the drug concentration-time curve within a dosing interval at steady states
Part I: each period (Group A, B, C, D) Part II: Group A, B
Measured: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Tmax,ss: Time of maximum concentration at steady state
Part I: each period (Group A, B, C, D) Part II: Group A, B
Measured: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
T1/2: Elimination half-life
Part I: each period (Group A, B, C, D) Part II: Group A, B
Measured: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Percentage of total time that the intragastric pH was above 4
Part I
Measured: Period 1 Day -1 and Group A, C Day 7 0~24 hours
Percentage of total time that the intragastric pH was above 4
Part II
Measured: Day -1, Day 1, Day 7 0~24 hours
Percentage of total time that the intragastric pH was above 6
Part I
Measured: Period 1 day -1 and Group A, C Day 7 0~24 hours
Percentage of total time that the intragastric pH was above 6
Part II
Measured: Day -1, Day 1, Day 7 0~24 hours
Serum gastrin concentration profile
Part I
Measured: Period 1 Day -1 and Group A, C Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48 hours
Serum gastrin concentration profile
Part II
Measured: Day -1 pre-dose, 2, 4, 6, 8, 12 hours, Day 1 and 7 pre-dose, 2, 4, 6, 8, 12, 24, 48 hours
Number 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 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)
Number of Participants With Clinically Significant Vital Sign findings
Blood pressure(mmHg), pulse (beats/min) 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 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)
Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings
Ventricular rate(beats/min), RR, PR interval(msec), QRS duration(msec), 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 54~60 (Post-study visit of Part I) and Day 36~42 (Follow up visit of Part II)
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 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start8 Apr 2018
- Primary completion11 Jan 2019
- Study completion11 Jan 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.
- 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
- None (open label)
- Enrolment
- 48 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
- NCT03487562
- Sponsor's protocol ID
- DW_DWP14012003
- Status last verified
- Jun 2019
- First submitted
- 13 Mar 2018
- Last updated
- 26 Jun 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 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple Dose, Two-part Phase I Clinical Trial to Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of DWP14012 After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03487562
- Acronym / sponsor ID
- DW_DWP14012003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2018 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 4 Apr 2018 (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 randomized, open-label, multiple dose, two-part phase I clinical trial to compare the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after administrations of DWP14012 alone and combinations of DWP14012, Clarithromycin and Amoxicillin in healthy male subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: DWP14012 Amg, Drug: Clarithromycin, Drug: AmoxicillinPart I: A-B-D-C A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid |
| Sequence 2 | Experimental | Drug: DWP14012 Amg, Drug: Clarithromycin, Drug: AmoxicillinPart I: B-C-A-D A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid |
| Sequence 3 | Experimental | Drug: DWP14012 Amg, Drug: Clarithromycin, Drug: AmoxicillinPart I: C-D-B-A A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid |
| Sequence 4 | Experimental | Drug: DWP14012 Amg, Drug: Clarithromycin, Drug: AmoxicillinPart I: D-A-C-B A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid |
| A | Experimental | Drug: DWP14012 Bmg, Drug: Clarithromycin, Drug: AmoxicillinPart II: (DWP14012 B mg + Clarithromycin 500 mg + Amoxicillin 1g) bid |
| B | Experimental | Drug: DWP14012 Amg, Drug: Clarithromycin, Drug: AmoxicillinPart II: (DWP14012 A mg + Clarithromycin 500 mg + Amoxicillin 1g) bid |
| C | Experimental | Drug: Clarithromycin, Drug: Amoxicillin, Drug: LansoprazolePart II: (Lansoprazole 30 mg + Clarithromycin 500 mg + Amoxicillin 1g) bid |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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
- Part I: Those who have been helicobacter pylori negative at screening Part II: Those who have been helicobacter pylori positive at screening
- 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 (4 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 whose plasma AST (SGOT) and ALT (SGPT) exceed to the upper limit of the normal range
- 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 |
|---|---|---|
| DWP14012 AmgDWP14012 Amg | Drug | B, Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| DWP14012 BmgDWP14012 Bmg | Drug | A |
| ClarithromycinClarithromycin 500 mg | Drug | A, B, C, Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| AmoxicillinAmoxicillin 1 g | Drug | A, B, C, Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| LansoprazoleLansoprazole 30 mg | Drug | C |
Primary outcome
Cmax,ss: Maximum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state
Time frame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Part I: each period (Group A, B, C, D) Part II: Group A, B
Cmin,ss: Minimum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state
Time frame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Part I: each period (Group A, B, C, D) Part II: Group A, B
Cav,ss: Average concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state
Time frame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Part I: each period (Group A, B, C, D) Part II: Group A, B
AUCt,ss: Area under the drug concentration-time curve within a dosing interval at steady states
Time frame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Part I: each period (Group A, B, C, D) Part II: Group A, B
Tmax,ss: Time of maximum concentration at steady state
Time frame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Part I: each period (Group A, B, C, D) Part II: Group A, B
T1/2: Elimination half-life
Time frame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Part I: each period (Group A, B, C, D) Part II: Group A, B
Percentage of total time that the intragastric pH was above 4
Time frame: Period 1 Day -1 and Group A, C Day 7 0~24 hours
Part I
Percentage of total time that the intragastric pH was above 4
Time frame: Day -1, Day 1, Day 7 0~24 hours
Part II
Percentage of total time that the intragastric pH was above 6
Time frame: Period 1 day -1 and Group A, C Day 7 0~24 hours
Part I
Percentage of total time that the intragastric pH was above 6
Time frame: Day -1, Day 1, Day 7 0~24 hours
Part II
Serum gastrin concentration profile
Time frame: Period 1 Day -1 and Group A, C Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48 hours
Part I
Serum gastrin concentration profile
Time frame: Day -1 pre-dose, 2, 4, 6, 8, 12 hours, Day 1 and 7 pre-dose, 2, 4, 6, 8, 12, 24, 48 hours
Part II
Number of participants with Adverse Events (AE)
Time frame: Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)
All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate and severe
Number of Participants With Clinically Significant Vital Sign findings
Time frame: Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)
Blood pressure(mmHg), pulse (beats/min) 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 54~60 (Post-study visit of Part I) and Day 36~42 (Follow up visit of Part II)
Ventricular rate(beats/min), RR, PR interval(msec), QRS duration(msec), 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 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)
Hematology, Blood chemistry, Coagulation and Urinalysis were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability.
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 26 Jun 2019.
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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 Amg, DWP14012 Bmg and Clarithromycin 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 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: finished, as of the sponsor's last update on 26 Jun 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?
Cmax,ss: Maximum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state (time frame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours). The study lists 16 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 26 Jun 2019.