Clinical Pharmacology, Healthy Volunteer StudyPhase 1QT/QTcNCT01986894
A Phase 1 QT Study in Healthy Male Subjects
A Phase 1 study testing Pomalidomide and Moxifloxacin in people with Clinical Pharmacology, Healthy Volunteer Study, run by Celgene at 1 site in United States.
Trial summary
This is a single-center, randomized, double-blind crossover study with four treatments, four periods and four sequences to investigate the effects of orally administered pomalidomide on QT interval. The study will be conducted in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Pharmacology, Healthy Volunteer Study
- What is being tested?
- Pomalidomide and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2013to 2 Dec 2013
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Must understand and voluntarily sign a written informed consent (ICD) prior to any study related procedures being performed.
- 2. Must be able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules 3. Healthy male of any race between 18 to 50 years of age (inclusive) at the time of signing the ICD, and in good health as determined by a physical exam (P)E.
- 4. Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential (FCBP) while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
- True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Period abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.
- 5. Must have a body-mass index (BMI) between 18 and 30 kg/m2 (inclusive). 6. Clinical laboratory tests must be within normal limits or acceptable to the Investigator.
- 7. Subject must be afebrile, with supine systolic blood pressure (BP): 90 to 140 mmHg, supine diastolic BP: 60 to 90 mmHg, and pulse rate (PR): 40 to 110 bpm.
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- At screening: After the supine measurements, when BP and pulse rate are measured again after 5 minutes of standing, there shall be no more than a 20 mmHg drop in systolic BP or no more than a 10 mmHg drop in diastolic BP and/or no more than a 20 bpm increase in pulse rate associated with clinical manifestation of postural hypotension.
- 8. Must have a normal or clinically acceptable 12-lead electrocardiogram (ECG) at screening; must have a QTcF value ≤ 430 msec.
- 9. Must agree to refrain from donating sperm or semen while participating in this study and for at least 28 days following the last dose of study drug.
- 10. Must agree to refrain from donating blood or plasma (other than for this study) while participating in this study and for at least 28 days following the last dose of study drug.
Who cannot join
- 1. History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular (including hypertension, atherosclerosis, heart failure, supraventricular or ventricular arrhythmias and stroke [Cerebral Vascular Accident (CVA)] or transient ischemic attack [TIA]), psychological, pulmonary (including asthma and chronic obstructive pulmonary disease [COPD], treated or not treated), metabolic, endocrine, hematological, allergic disease, drug allergies, known hypersensitivity to a member of the class of IMiDs®, known hypersensitivity to moxifloxacin or other major disorders.
- 2. Any condition which places the subject at unacceptable risk if he was to participate in the study, or confounds the ability to interpret data from the study.
- 3. Have a first degree relative (parent, sibling, child) with Long QT Syndrome. 4. A hemoglobin level of less than 12.0 g/dL. 5. Abnormal Electrocardiogram (ECG) findings as follows:
- Heart rate < 40 or > 110 bpm, after resting in the supine position for 5 minutes;
- Pulse rate (PR) interval > 220 msec;
- QRS interval > 120 including any degree of bundle branch block;
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- QTcF < 300 or > 430 msec;
- Evidence of pre-excitation (e.g., Wolfe-Parkinson-White syndrome);
- Cardiac pacemaker;
- Atrial fibrillation / flutter. 6. QRS and/or T wave that the Investigator judges to be unfavorable for consistently accurate QT measurements (e.g., indistinct QRS onset, low amplitude T wave, inverted or terminally inverted T wave, merged T/U waves, indistinct T wave offset, or prominent U wave that affects QT measurement).
- 7. Neuromuscular artifact that cannot readily be eliminated. 8. Subjects with hypokalemia and/or hypomagnesemia condition. 9. Used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days of the first dose administration, unless sponsor agreement is obtained.
- 10. Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration, unless sponsor agreement is obtained.
- 11. Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME), e.g., bariatric procedure. Appendectomy and cholecystectomy are acceptable.
- 12. Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
- 13. History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before dosing, or positive drug test reflecting consumption of illicit drugs.
- 14. History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing, or positive alcohol screen.
- 15. Known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HbsAg) or hepatitis C virus antibody (HCV Ab), or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
- 16. Exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
- 17. Cotinine level at screening or on Day 2 of Period 1 indicates subject is a moderate or heavy smoker.
- 18. History of autonomic dysfunction (e.g., history of fainting or orthostatic hypotension).
- 19. Subjects who are part of the clinical staff personnel or family members of the clinical site staff.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Four Period Crossover Study to Investigate the Effects of Pomalidomide (CC 4047) on the QT Interval in Healthy Male Subjects
This is a single-center, randomized, double-blind crossover study with four treatments, four periods and four sequences to investigate the effects of orally administered pomalidomide on QT interval. The study will be conducted in healthy male subjects. Pomalidomide (clinically indicated dose for multiple myeloma [MM] as per the United States Package Insert [USPI] of 4 mg and supratherapeutic dose of 20 mg) and placebo treatments will be double-blinded. Moxifloxacin (positive control) will be administered in an open-label fashion to determine the sensitivity of the assay. The core electrocardiogram (ECG) laboratory and ECG readers will be blinded to all study treatments and sequences.
Read the detailed description
A total of 72 male subjects will be randomized and enrolled, with 18 subjects assigned to each treatment sequence. For each treatment sequence, each subject will participate in a screening phase, four baseline phases, four treatment periods and a follow up visit. Within 28 days prior to Period 1 dosing, subjects will sign an informed consent document (ICD) and undergo screening procedures to confirm eligibility. Qualifying subjects will return to the clinical site on Day -2 of Period 1 to begin baseline assessments, and will be domiciled at the clinical site from Day -2 to Day 2 of Period 1. For all remaining study periods, subjects will return to the clinical site on Day -1 to begin baseline assessments, and will be domiciled at the clinical site from Day -1 to Day 2. Subjects will be assigned randomly to one of four treatment sequences and will receive a single dose of the assigned treatment on Day 1 of each study period. There will be a minimum of 7 days and no more than 14 days between each dose.
Subjects will begin an overnight fast of at least 8 hours prior to the start of continuous Holter monitoring on Day 1 (and Day 1 in Period 1). On the morning of Day 1 (and Day -1 in Period 1), continuous Holter monitoring for approximately 24 hours will be performed. Triplicate ECGs will be extracted for analysis at specific predose and postdose timepoints (or equivalent times on Day -1 of Period 1). Blood samples will be collected at pre specified timepoints for pharmacokinetic (PK) and clinical laboratory assessments. Safety will be monitored throughout the study.
During each study period, subjects will be discharged from the clinical site on Day 2 upon satisfactory safety review and completion of the required study procedures. A safety follow up will be conducted by telephone 5 to 7 days following discharge in Period 4. In the event that a subject discontinues from the study, an early termination visit will be performed.
- Being tested
- Placebo, Pomalidomide, Moxifloxacin
- Keywords
- TQT, Pharmacokinetic, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single oral dose of Placebo
PomalidomideDrug
Also called POMALYST®
Single oral dose of 4 mg pomalidomide
PomalidomideDrug
Also called POMALYST®
Single oral dose of 20 mg pomalidomide
MoxifloxacinDrug
Also called AVELOX®
Single oral dose of 400 mg moxifloxacin tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 (placebo) | Placebo comparator | Five placebo capsules matching the appearance of the 4 mg pomalidomide capsule will be administered orally on the morning of Day 1 Receives: Drug: Placebo |
| Treatment 2 (4 mg pomalidomide) | Experimental | Five capsules (one 4 mg pomalidomide capsule and four placebo capsules matching the appearance of the 4 mg pomalidomide capsule) will be administered orally on the morning of Day 1 Receives: Drug: Pomalidomide |
| Treatment 3 (20 mg pomalidomide) | Experimental | Five 4 mg pomalidomide capsules will be administered orally on the morning of Day 1 Receives: Drug: Pomalidomide |
| Treatment 4 (moxifloxacin) | Active comparator | One 400 mg moxifloxacin tablet (AVELOX®, moxifloxacin hydrochloride, Bayer Pharmaceuticals Corporation) will be administered orally on the morning of Day 1 Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time matched, baseline corrected change from placebo of QTcF
To evaluate the effect of pomalidomide on the time matched changes from placebo in the baseline adjusted QT interval of the electrocardiogram (ECG) using the Fridericia correction method (QTcF)
Measured: From before dosing until 23 hours after dosing
Categorical analyses on ECG intervals and changes in ECG morphology
Measured: From before dosing until 23 hours after dosing
Secondary outcomes (9)
Time matched, baseline corrected changes from placebo of other ECG intervals (RR, PR, QRS) and categorical analyses on ECG intervals and changes in ECG morphology
To evaluate the change from placebo in selected ECG parameters (heart rate, PR interval, QRS interval, uncorrected QT interval and morphological patterns) following pomalidomide treatment
Measured: From before dosing until 23 hours after dosing
Safety
To assess the safety and tolerability of single oral doses of pomalidomide
Measured: 2 months (from screening visit until end of study
Pharmacokinetics - Cmax
Maximum observed plasma concentration
Measured: From before dosing until 32 hours after dosing
Pharmacokinetics - Tmax
Time to Cmax
Measured: From before dosing until 32 hours after dosing
Pharmacokinetics - AUCinf
Area under the plasma concentration time curve from time zero extrapolated to infinity
Measured: From before dosing until 32 hours after dosing
Pharmacokinetics - AUCt
Area under the plasma concentration time curve from time zero to the last quantifiable concentration
Measured: From before dosing until 32 hours after dosing
Pharmacokinetics - t1/2
Terminal phase elimination half-life
Measured: From before dosing until 32 hours after dosing
Pharmacokinetics - CL/F
Apparent total plasma clearance when dosed orally
Measured: From before dosing until 32 hours after dosing
Pharmacokinetics - Vz/F
Apparent total volume of distribution when dosed orally, based on the terminal phase
Measured: From before dosing until 32 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study start18 Oct 2013
- Primary completion2 Dec 2013
- Study completion2 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Pharmacology, Healthy Volunteer StudyStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward O'Mara, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986894
- Sponsor's protocol ID
- CC-4047-CP-010
- Acronym
- QT/QTc
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2013
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Four Period Crossover Study to Investigate the Effects of Pomalidomide (CC 4047) on the QT Interval in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01986894
- Acronym / sponsor ID
- QT/QTc / CC-4047-CP-010
- Keywords
- TQT, Pharmacokinetic, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2013 (actual)
- Primary completion
- 2 Dec 2013 (actual)
- Study completion
- 2 Dec 2013 (actual)
- First posted
- 19 Nov 2013 (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 single-center, randomized, double-blind crossover study with four treatments, four periods and four sequences to investigate the effects of orally administered pomalidomide on QT interval. The study will be conducted in healthy male subjects. Pomalidomide (clinically indicated dose for multiple myeloma [MM] as per the United States Package Insert [USPI] of 4 mg and supratherapeutic dose of 20 mg) and placebo treatments will be double-blinded. Moxifloxacin (positive control) will be administered in an open-label fashion to determine the sensitivity of the assay. The core electrocardiogram (ECG) laboratory and ECG readers will be blinded to all study treatments and sequences.
Detailed description
A total of 72 male subjects will be randomized and enrolled, with 18 subjects assigned to each treatment sequence. For each treatment sequence, each subject will participate in a screening phase, four baseline phases, four treatment periods and a follow up visit. Within 28 days prior to Period 1 dosing, subjects will sign an informed consent document (ICD) and undergo screening procedures to confirm eligibility. Qualifying subjects will return to the clinical site on Day -2 of Period 1 to begin baseline assessments, and will be domiciled at the clinical site from Day -2 to Day 2 of Period 1. For all remaining study periods, subjects will return to the clinical site on Day -1 to begin baseline assessments, and will be domiciled at the clinical site from Day -1 to Day 2. Subjects will be assigned randomly to one of four treatment sequences and will receive a single dose of the assigned treatment on Day 1 of each study period. There will be a minimum of 7 days and no more than 14 days between each dose.
Subjects will begin an overnight fast of at least 8 hours prior to the start of continuous Holter monitoring on Day 1 (and Day 1 in Period 1). On the morning of Day 1 (and Day -1 in Period 1), continuous Holter monitoring for approximately 24 hours will be performed. Triplicate ECGs will be extracted for analysis at specific predose and postdose timepoints (or equivalent times on Day -1 of Period 1). Blood samples will be collected at pre specified timepoints for pharmacokinetic (PK) and clinical laboratory assessments. Safety will be monitored throughout the study.
During each study period, subjects will be discharged from the clinical site on Day 2 upon satisfactory safety review and completion of the required study procedures. A safety follow up will be conducted by telephone 5 to 7 days following discharge in Period 4. In the event that a subject discontinues from the study, an early termination visit will be performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 (placebo) | Placebo comparator | Drug: PlaceboFive placebo capsules matching the appearance of the 4 mg pomalidomide capsule will be administered orally on the morning of Day 1 |
| Treatment 2 (4 mg pomalidomide) | Experimental | Drug: PomalidomideFive capsules (one 4 mg pomalidomide capsule and four placebo capsules matching the appearance of the 4 mg pomalidomide capsule) will be administered orally on the morning of Day 1 |
| Treatment 3 (20 mg pomalidomide) | Experimental | Drug: PomalidomideFive 4 mg pomalidomide capsules will be administered orally on the morning of Day 1 |
| Treatment 4 (moxifloxacin) | Active comparator | Drug: MoxifloxacinOne 400 mg moxifloxacin tablet (AVELOX®, moxifloxacin hydrochloride, Bayer Pharmaceuticals Corporation) will be administered orally on the morning of Day 1 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 1. Must understand and voluntarily sign a written informed consent (ICD) prior to any study related procedures being performed.
- 2. Must be able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules 3. Healthy male of any race between 18 to 50 years of age (inclusive) at the time of signing the ICD, and in good health as determined by a physical exam (P)E.
- 4. Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential (FCBP) while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
- True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Period abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.
- 5. Must have a body-mass index (BMI) between 18 and 30 kg/m2 (inclusive). 6. Clinical laboratory tests must be within normal limits or acceptable to the Investigator.
Key exclusion criteria (21 listed)
- 1. History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular (including hypertension, atherosclerosis, heart failure, supraventricular or ventricular arrhythmias and stroke [Cerebral Vascular Accident (CVA)] or transient ischemic attack [TIA]), psychological, pulmonary (including asthma and chronic obstructive pulmonary disease [COPD], treated or not treated), metabolic, endocrine, hematological, allergic disease, drug allergies, known hypersensitivity to a member of the class of IMiDs®, known hypersensitivity to moxifloxacin or other major disorders.
- 2. Any condition which places the subject at unacceptable risk if he was to participate in the study, or confounds the ability to interpret data from the study.
- 3. Have a first degree relative (parent, sibling, child) with Long QT Syndrome. 4. A hemoglobin level of less than 12.0 g/dL. 5. Abnormal Electrocardiogram (ECG) findings as follows:
- 7. Neuromuscular artifact that cannot readily be eliminated. 8. Subjects with hypokalemia and/or hypomagnesemia condition. 9. Used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days of the first dose administration, unless sponsor agreement is obtained.
- 10. Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration, unless sponsor agreement is obtained.
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 |
|---|---|---|
| PlaceboSingle oral dose of Placebo | Drug | Treatment 1 (placebo) |
| PomalidomideAlso: POMALYST®Single oral dose of 4 mg pomalidomide | Drug | Treatment 2 (4 mg pomalidomide) |
| PomalidomideAlso: POMALYST®Single oral dose of 20 mg pomalidomide | Drug | Treatment 3 (20 mg pomalidomide) |
| MoxifloxacinAlso: AVELOX®Single oral dose of 400 mg moxifloxacin tablet | Drug | Treatment 4 (moxifloxacin) |
Primary outcome
Time matched, baseline corrected change from placebo of QTcF
Time frame: From before dosing until 23 hours after dosing
To evaluate the effect of pomalidomide on the time matched changes from placebo in the baseline adjusted QT interval of the electrocardiogram (ECG) using the Fridericia correction method (QTcF)
Categorical analyses on ECG intervals and changes in ECG morphology
Time frame: From before dosing until 23 hours after dosing
9 secondary outcomes
Time matched, baseline corrected changes from placebo of other ECG intervals (RR, PR, QRS) and categorical analyses on ECG intervals and changes in ECG morphology
Time frame: From before dosing until 23 hours after dosing
Safety
Time frame: 2 months (from screening visit until end of study
Pharmacokinetics - Cmax
Time frame: From before dosing until 32 hours after dosing
Pharmacokinetics - Tmax
Time frame: From before dosing until 32 hours after dosing
Pharmacokinetics - AUCinf
Time frame: From before dosing until 32 hours after dosing
Pharmacokinetics - AUCt
Time frame: From before dosing until 32 hours after dosing
Pharmacokinetics - t1/2
Time frame: From before dosing until 32 hours after dosing
Pharmacokinetics - CL/F
Time frame: From before dosing until 32 hours after dosing
Pharmacokinetics - Vz/F
Time frame: From before dosing until 32 hours after dosing
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 12 Nov 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.
Edward O'Mara, MD study director
Celgene Corporation
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 Pomalidomide and Moxifloxacin in people with Clinical Pharmacology, Healthy Volunteer Study, run by Celgene at 1 site in United States.
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 10 inclusion and 21 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 12 Nov 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 United States. 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?
Time matched, baseline corrected change from placebo of QTcF (time frame: From before dosing until 23 hours after dosing). The study lists 2 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 12 Nov 2019.