Qt Interval, Variation inPhase 1NCT03822520
Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib
A Phase 1 study testing Celecoxib, Moxifloxacin and Water in people with Qt Interval, Variation in, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is conducted to evaluate effect on QT/QTc Interval after multiple dose of celecoxib among healthy adult volunteers. It is randomized, open-label, negative and postive control, and crossover study. Volunteers will be mainly checked up through ECG to find out changes of QT/QTc interval during the study. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Qt Interval, Variation in
- What is being tested?
- Celecoxib, Moxifloxacin and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jun 2017to 25 May 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults between 19-year-old and 40-year-old during the screening day
- BMI between 19 kg/m² and 30 kg/m² during the screening day
- Be able to give an informed consent form after understanding for reasonable explanation of clinical trial's purpose, contents and characteristics of clinical drugs
- Wiling to participate whole clinical trial periods
Who cannot join
- Person who is able to clinically affect to the study through ECG result during the screening day
- Has critical issue for Torsade de points from heart failure, hypopotassemia, arrhythmia etc., or family history for long QT syndrome, sudden cardiac death.
- Was suffered, or is suffering from like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study
- Has allergy which is required the treatment or hypersensitive from drugs such as aspirin, anti-biotics, anti-depressants, etc.
- Was administered any drug of other clinical study within 90 days from the randomization day.
- Donated whole blood within 60days or apheresis within 30 days from the randomization day.
Show all 17Show fewer
- Took any medicine or oriental medicine within 2 weeks, or general pharmaceuticals within 7 days from the randomization day. (For general pharmaceuticals circumstances, PI could decide whether he/she is suitable for the study)
- No intention to take contraceptive which is approved as clinical way, or is planning on giving their sperm or egg during the whole clinical trial.
- Average alcohol consumption per week: >140g
- Average smoking per day: >20
- Average grapefruit juice consumption per day: >4 glasses
- systolic blood pressure <100 mmHg or >150 mmHg, or diastolic pressure <70 mmHg or >100mmHg
- Over 2 times from the maximum reference interval of AST and ALT levels in the blood.
- eGFR by MDRD from creatinine in the blood is less than 30 mL/min.
- doesn't show negative reaction from HIV Test, B hepatitis test, or C hepatitis test
- For woman, doesn't show negative reaction from pregnancy test
- PI decides the person is not suitable to participate the clinical study with other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Negative and Positive Control, Crossover Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib in Healthy Adult Volunteers
This study is conducted to evaluate effect on QT/QTc Interval after multiple dose of celecoxib among healthy adult volunteers. It is randomized, open-label, negative and postive control, and crossover study. Volunteers will be mainly checked up through ECG to find out changes of QT/QTc interval during the study.
- Conditions
- Qt Interval, Variation in
- Being tested
- Celecoxib, Moxifloxacin, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
Celecoxib 400mg capsule
MoxifloxacinDrug
Also called Avelox
Moxifloxacin 400mg tablet
WaterOther
Pure water 150ml
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib, Moxifloxacin, Water in order | Experimental | 1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
Wash-out period (3~6 days)
2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days)
3. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Receives: Drug: Celecoxib; Drug: Moxifloxacin; Other: Water |
| Celecoxib, Water, Moxifloxacin in order | Experimental | 1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
Wash-out period (3~6 days)
2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days)
3. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Receives: Drug: Celecoxib; Drug: Moxifloxacin; Other: Water |
| Moxifloxacin, Water, Celecoxib in order | Experimental | 1. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days)
2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days)
3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Receives: Drug: Celecoxib; Drug: Moxifloxacin; Other: Water |
| Water, Moxifloxacin, Celecoxib in order | Experimental | 1. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days)
2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days)
3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Receives: Drug: Celecoxib; Drug: Moxifloxacin; Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QTc interval, read manually
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Measured: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
Secondary outcomes (14)
Change in QTc , measured automatically
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Measured: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
ventricular rate, measured automatically
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Measured: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
PR duration, measured automatically
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Measured: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
RR duration, measured automatically
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Measured: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
QRS duration, measured automatically
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Measured: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
Area under the curve within a dosing interval at steady state
which is analyzed at the date of final administration of celecoxib
Measured: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Maximum concentration at steady state
which is analyzed at the date of final administration of celecoxib
Measured: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Time to maximum concentration at steady state
which is analyzed at the date of final administration of celecoxib
Measured: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Minimum concentration at steady state
which is analyzed at the date of final administration of celecoxib
Measured: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Area under the concentration-time curve time zero to the time of the last quantifiable concentration
which is analyzed at the date of final administration of moxifloxacin
Measured: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Maximum concentration
which is analyzed at the date of final administration of moxifloxacin
Measured: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Time to maximum concentration
which is analyzed at the date of final administration of moxifloxacin
Measured: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Half-life
which is analyzed at the date of final administration of moxifloxacin
Measured: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
The apparent clearance
which is analyzed at the date of final administration of moxifloxacin
Measured: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start30 Jun 2017
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Qt Interval, Variation inStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Ryul Kim, Samsung Medical Center
- Investigators
- JUNGRYUL KIM, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822520
- Sponsor's protocol ID
- 2016-11-053
- Status last verified
- Jan 2019
- First submitted
- 8 Nov 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim S, Lee H, Ko JW, Kim JR. Effects of Celecoxib on the QTc Interval: A Thorough QT/QTc Study. Clin Ther. 2019 Nov;41(11):2204-2218. doi: 10.1016/j.clinthera.2019.09.004. Epub 2019 Sep 26.
PubMed 31564512
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Negative and Positive Control, Crossover Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03822520
- Acronym / sponsor ID
- 2016-11-053
- Conditions
- Qt Interval, Variation in
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 30 Jan 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.
This study is conducted to evaluate effect on QT/QTc Interval after multiple dose of celecoxib among healthy adult volunteers. It is randomized, open-label, negative and postive control, and crossover study. Volunteers will be mainly checked up through ECG to find out changes of QT/QTc interval during the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Celecoxib, Moxifloxacin, Water in order | Experimental | Drug: Celecoxib, Drug: Moxifloxacin, Other: Water1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3~6 days) 3. Intervention Pure water: Water 150ml by mouth without any drug, once for one day |
| Celecoxib, Water, Moxifloxacin in order | Experimental | Drug: Celecoxib, Drug: Moxifloxacin, Other: Water1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3~6 days) 3. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day |
| Moxifloxacin, Water, Celecoxib in order | Experimental | Drug: Celecoxib, Drug: Moxifloxacin, Other: Water1. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days |
| Water, Moxifloxacin, Celecoxib in order | Experimental | Drug: Celecoxib, Drug: Moxifloxacin, Other: Water1. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults between 19-year-old and 40-year-old during the screening day
- BMI between 19 kg/m² and 30 kg/m² during the screening day
- Be able to give an informed consent form after understanding for reasonable explanation of clinical trial's purpose, contents and characteristics of clinical drugs
- Wiling to participate whole clinical trial periods
Key exclusion criteria (17 listed)
- Person who is able to clinically affect to the study through ECG result during the screening day
- Has critical issue for Torsade de points from heart failure, hypopotassemia, arrhythmia etc., or family history for long QT syndrome, sudden cardiac death.
- Was suffered, or is suffering from like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study
- Has allergy which is required the treatment or hypersensitive from drugs such as aspirin, anti-biotics, anti-depressants, etc.
- Was administered any drug of other clinical study within 90 days from the randomization day.
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 |
|---|---|---|
| CelecoxibAlso: CelebrexCelecoxib 400mg capsule | Drug | Celecoxib, Moxifloxacin, Water in order, Celecoxib, Water, Moxifloxacin in order, Moxifloxacin, Water, Celecoxib in order, Water, Moxifloxacin, Celecoxib in order |
| MoxifloxacinAlso: AveloxMoxifloxacin 400mg tablet | Drug | Celecoxib, Moxifloxacin, Water in order, Celecoxib, Water, Moxifloxacin in order, Moxifloxacin, Water, Celecoxib in order, Water, Moxifloxacin, Celecoxib in order |
| WaterPure water 150ml | Other | Celecoxib, Moxifloxacin, Water in order, Celecoxib, Water, Moxifloxacin in order, Moxifloxacin, Water, Celecoxib in order, Water, Moxifloxacin, Celecoxib in order |
Primary outcome
Change in QTc interval, read manually
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
14 secondary outcomes
Change in QTc , measured automatically
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
ventricular rate, measured automatically
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
PR duration, measured automatically
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
RR duration, measured automatically
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
QRS duration, measured automatically
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
Area under the curve within a dosing interval at steady state
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Maximum concentration at steady state
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Time to maximum concentration at steady state
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Minimum concentration at steady state
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Area under the concentration-time curve time zero to the time of the last quantifiable concentration
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Maximum concentration
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Time to maximum concentration
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Half-life
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
The apparent clearance
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
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 30 Jan 2019.
- Derived from this study: PubMed 31564512Kim S, Lee H, Ko JW, Kim JR. Effects of Celecoxib on the QTc Interval: A Thorough QT/QTc Study. Clin Ther. 2019 Nov;41(11):2204-2218. doi: 10.1016/j.clinthera.2019.09.004. Epub 2019 Sep 26.
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.
JUNGRYUL KIM, MD, PhD principal investigator
Samsung Medical Center
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 Celecoxib, Moxifloxacin and Water in people with Qt Interval, Variation in, run by Samsung Medical Center 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 17 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 30 Jan 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?
Change in QTc interval, read manually (time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03822520, which also lists 1 linked publication.
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 30 Jan 2019.