Diabetes Mellitus, Type 2Phase 1NCT01340911
A Study in Healthy Male Volunteers to Investigate Different Doses of a New Drug for the Treatment of Metabolic Diseases
A Phase 1 study testing SRT3025 in people with Diabetes Mellitus, Type 2, run by Sirtris, a GSK Company at 1 site in United Kingdom.
Trial summary
The main purpose of the study is to see how safe SRT3025 (study drug) is when given at different doses. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- SRT3025
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jun 2011to 24 Nov 2011
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the Sirtris Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male between 18 and 55 years of age, inclusive, at the time of signing the informed consent.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods that is permitted in the study. This criterion must be followed from the time of the first dose of study medication until the End of Study Safety Follow-up Visit.
- Body weight ≥50 kilogram (kg) and body mass index (BMI) within the range 18-29.9 kg/m^2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase and bilirubin ≥ 1.5x upper limit normal (ULN) (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin >35%).
- Have an abnormal 12-lead electrocardiogram (ECG) or an ECG with abnormality considered to be clinically significant in the opinion of the Investigator. Specifically, single QTcB > 450 msec; or QTc > 480 msec in subjects with Bundle Branch Block.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
Show all 15Show fewer
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units. One unit is equivalent to 8 gram (g) of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
- The subject has participated in a clinical trial and has received an investigational product within the 3 months prior to the first dosing day in the current study.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sirtris Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Sirtris Medical Monitor, contraindicates his/her participation.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Subjects who have asthma, history of asthma, are experiencing flu-like symptoms, or have had an upper respiratory tract infection within two weeks of screening.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Harrow, Middlesex, HA1 3UJ
About this study
Official title: A Randomized, Placebo-Controlled, Single-Blind, Dose-Escalation, First-Time-in-Human Study to Assess the Safety and Pharmacokinetics of Single and Repeat Doses of SRT3025 in Normal Healthy Volunteers
The main purpose of the study is to see how safe SRT3025 (study drug) is when given at different doses. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. A further aim is to look at how taking the study drug after eating might change this process.
Read the detailed description
SRT3025 is being developed for the treatment of metabolic diseases. This study is the first administration of SRT3025 in humans and seeks to establish the initial safety, tolerability, and pharmacokinetic (PK) profile of SRT3025 (and any metabolites, if analyzed) before proceeding to future Phase 1 studies or Phase 2 patient studies.
This protocol details a Phase 1, randomized, placebo-controlled, single-blind, dose escalation study to determine the safety, tolerability, and PK profile of SRT3025 in healthy male subjects. The study will be conducted in two parts. In Part 1A, 6 Cohorts of subjects will receive single escalating doses of SRT3025. In Part 1B, an additional one to two cohorts may be enrolled to investigate the effect of a moderate fat/calorie meal on single dose PK endpoints. In Part 2A, up to three cohorts may be enrolled to receive 14-day repeat doses of SRT3025 chosen from the Part 1A safety, tolerability, and PK data. In Part 2B, one to two additional cohorts may receive 14-day repeat doses of SRT3025 in combination with a moderate fat/calorie meal.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- SRT3025, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRT3025Drug
SRT3025 will be supplied as hard gelatin capsules containing either 27.4 mg (25 mg SRT3025 free base equivalent) or 274 mg (250 mg SRT3025 free base equivalent) of SRT3025 HCl monohydrate drug substance.
PlaceboDrug
For placebo product, the SRT3025 drug substance will be replaced by Microcrystalline Cellulose (Avicel® PH 105) to match the SRT3025 investigational product.
| Study group | Role | What they receive |
|---|---|---|
| Part 1A, Cohorts 1-6 | Active comparator | Approximately 48 healthy male subjects will be enrolled into 6 separate cohorts (8 subjects per cohort). Each Cohort of subjects will be dosed sequentially, approximately one week apart, at escalating doses. Within each cohort, 6 subjects will be randomized to receive a single dose of SRT3025, and 2 will be randomized to receive a single dose of placebo.
The following are the planned doses for Cohorts 1-6, with Cohort 1 being the lowest dose and Cohort 6 being the highest dose: 50, 150, 500, 1000, 2000, and 3000mg of SRT3025. Dose level may be altered as appropriate during the study based on real time analysis of the safety, tolerability, and /or PK data. Dose adjustment may involve an increase or decrease in dose or dividing the total daily dose allowing for twice-daily dosing. Total daily dosing will not exceed 3000mg. Receives: Drug: SRT3025; Drug: Placebo |
| Part 1B, Cohorts 7-8 | Active comparator | One to two of the doses administered in Part 1A may be selected for administration with food, based on expected changes in SRT3025 exposures with food, as well as safety, tolerability, and PK data from Part 1A. If initiated, the effect of a single dose of SRT3025 with a moderate fat/calorie meal may be initiated concurrently with a cohort in Part 2 of the study. Approximately 6 subjects would be enrolled into each cohort in Part 1B. Receives: Drug: SRT3025 |
| Part 2A, Cohorts 9-11 | Active comparator | Approximately 16-24 healthy subjects will be enrolled into 2 to 3 cohorts (8 subjects per cohort) in Part 2A. Within each cohort, 6 subjects will be randomized to receive multiple doses of SRT3025, and 2 will be randomized to receive multiple doses of placebo. The repeat dosing component of the study will be initiated, and doses selected, based on the evaluation of safety, tolerability, and PK data from Part 1A. Subjects in Part 2A will be randomized to receive 14 consecutive days of dosing with SRT3025 or matched-placebo. Subjects in these Cohorts will be dosed sequentially (in the fasted state) approximately two weeks apart. Receives: Drug: SRT3025; Drug: Placebo |
| Part 2B, Cohorts 12-13 | Active comparator | If initiated, the effect of repeat doses of SRT3025 with moderate fat/calorie meals would occur in Part 2B (Cohorts 12 and 13). Each of these cohorts would enroll approximately 6 subjects. Receives: Drug: SRT3025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of a single dose of SRT3025 in healthy male subjects.
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of a single dose of SRT3025 in healthy male subjects.
Measured: 9 days
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of multiple doses of SRT3025 in healthy male subjects.
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of multiple doses of SRT3025 in healthy male subjects.
Measured: 21 days
Secondary outcomes (6)
Plasma levels of SRT3025 will be measured in all subjects that received a single dose of the study drug at fasted and fed states to assess the pharmacokinetics and bioavailability of SRT3025.
Plasma levels of SRT3025 will be measured in all subjects that received a single dose of the study drug at fasted and fed states to assess the pharmacokinetics and bioavailability of SRT3025.
Measured: 24 hours
Plasma levels of SRT3025 will be measured in all subjects that received multiple doses of the study drug at fasted and fed states to assess the pharmacokinetics and bioavailability of SRT3025.
Plasma levels of SRT3025 will be measured in all subjects that received multiple doses of the study drug at fasted and fed states to assess the pharmacokinetics and bioavailability of SRT3025.
Measured: 14 days
SRT3025 metabolite levels in urine and plasma will be measured in all subjects that received a single dose of SRT3025.
SRT3025 metabolite levels in urine and plasma will be measured in all subjects that received a single dose of SRT3025.
Measured: 24 hours
SRT3025 metabolite levels in urine and plasma will be measured in all subjects that received multiple dose of SRT3025.
SRT3025 metabolite levels in urine and plasma will be measured in all subjects that received multiple dose of SRT3025.
Measured: 15 days
Plasma levels of SRT3025 may be compared to the number and types of adverse events experienced by subjects receiving a single dose of SRT3025 to assess any relationship between plasma SRT3025 levels and adverse events.
Plasma levels of SRT3025 may be compared to the number and types of adverse events experienced by subjects receiving a single dose of SRT3025 to assess any relationship between plasma SRT3025 levels and adverse events.
Measured: 9 days
Plasma levels of SRT3025 may be compared to the number and types of adverse events experienced by subjects receiving multiple doses of SRT3025 to assess any relationship between plasma SRT3025 levels and adverse events.
Plasma levels of SRT3025 may be compared to the number and types of adverse events experienced by subjects receiving multiple doses of SRT3025 to assess any relationship between plasma SRT3025 levels and adverse events.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study start3 Jun 2011
- Primary completion24 Nov 2011
- Study completion24 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirtris, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340911
- Sponsor's protocol ID
- 115444
- Status last verified
- Oct 2017
- First submitted
- 21 Apr 2011
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Single-Blind, Dose-Escalation, First-Time-in-Human Study to Assess the Safety and Pharmacokinetics of Single and Repeat Doses of SRT3025 in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01340911
- Acronym / sponsor ID
- 115444
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Sirtris, a GSK CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2011 (actual)
- Primary completion
- 24 Nov 2011 (actual)
- Study completion
- 24 Nov 2011 (actual)
- First posted
- 25 Apr 2011 (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.
The main purpose of the study is to see how safe SRT3025 (study drug) is when given at different doses. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. A further aim is to look at how taking the study drug after eating might change this process.
Detailed description
SRT3025 is being developed for the treatment of metabolic diseases. This study is the first administration of SRT3025 in humans and seeks to establish the initial safety, tolerability, and pharmacokinetic (PK) profile of SRT3025 (and any metabolites, if analyzed) before proceeding to future Phase 1 studies or Phase 2 patient studies.
This protocol details a Phase 1, randomized, placebo-controlled, single-blind, dose escalation study to determine the safety, tolerability, and PK profile of SRT3025 in healthy male subjects. The study will be conducted in two parts. In Part 1A, 6 Cohorts of subjects will receive single escalating doses of SRT3025. In Part 1B, an additional one to two cohorts may be enrolled to investigate the effect of a moderate fat/calorie meal on single dose PK endpoints. In Part 2A, up to three cohorts may be enrolled to receive 14-day repeat doses of SRT3025 chosen from the Part 1A safety, tolerability, and PK data. In Part 2B, one to two additional cohorts may receive 14-day repeat doses of SRT3025 in combination with a moderate fat/calorie meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1A, Cohorts 1-6 | Active comparator | Drug: SRT3025, Drug: PlaceboApproximately 48 healthy male subjects will be enrolled into 6 separate cohorts (8 subjects per cohort). Each Cohort of subjects will be dosed sequentially, approximately one week apart, at escalating doses. Within each cohort, 6 subjects will be randomized to receive a single dose of SRT3025, and 2 will be randomized to receive a single dose of placebo. The following are the planned doses for Cohorts 1-6, with Cohort 1 being the lowest dose and Cohort 6 being the highest dose: 50, 150, 500, 1000, 2000, and 3000mg of SRT3025. Dose level may be altered as appropriate during the study based on real time analysis of the safety, tolerability, and /or PK data. Dose adjustment may involve an increase or decrease in dose or dividing the total daily dose allowing for twice-daily dosing. Total daily dosing will not exceed 3000mg. |
| Part 1B, Cohorts 7-8 | Active comparator | Drug: SRT3025One to two of the doses administered in Part 1A may be selected for administration with food, based on expected changes in SRT3025 exposures with food, as well as safety, tolerability, and PK data from Part 1A. If initiated, the effect of a single dose of SRT3025 with a moderate fat/calorie meal may be initiated concurrently with a cohort in Part 2 of the study. Approximately 6 subjects would be enrolled into each cohort in Part 1B. |
| Part 2A, Cohorts 9-11 | Active comparator | Drug: SRT3025, Drug: PlaceboApproximately 16-24 healthy subjects will be enrolled into 2 to 3 cohorts (8 subjects per cohort) in Part 2A. Within each cohort, 6 subjects will be randomized to receive multiple doses of SRT3025, and 2 will be randomized to receive multiple doses of placebo. The repeat dosing component of the study will be initiated, and doses selected, based on the evaluation of safety, tolerability, and PK data from Part 1A. Subjects in Part 2A will be randomized to receive 14 consecutive days of dosing with SRT3025 or matched-placebo. Subjects in these Cohorts will be dosed sequentially (in the fasted state) approximately two weeks apart. |
| Part 2B, Cohorts 12-13 | Active comparator | Drug: SRT3025If initiated, the effect of repeat doses of SRT3025 with moderate fat/calorie meals would occur in Part 2B (Cohorts 12 and 13). Each of these cohorts would enroll approximately 6 subjects. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the Sirtris Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male between 18 and 55 years of age, inclusive, at the time of signing the informed consent.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods that is permitted in the study. This criterion must be followed from the time of the first dose of study medication until the End of Study Safety Follow-up Visit.
- Body weight ≥50 kilogram (kg) and body mass index (BMI) within the range 18-29.9 kg/m^2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Key exclusion criteria (15 listed)
- Aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase and bilirubin ≥ 1.5x upper limit normal (ULN) (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin >35%).
- Have an abnormal 12-lead electrocardiogram (ECG) or an ECG with abnormality considered to be clinically significant in the opinion of the Investigator. Specifically, single QTcB > 450 msec; or QTc > 480 msec in subjects with Bundle Branch Block.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
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 |
|---|---|---|
| SRT3025SRT3025 will be supplied as hard gelatin capsules containing either 27.4 mg (25 mg SRT3025 free base equivalent) or 274 mg (250 mg SRT3025 free base equivalent) of SRT3025 HCl monohydrate drug substance. | Drug | Part 1A, Cohorts 1-6, Part 1B, Cohorts 7-8, Part 2A, Cohorts 9-11, Part 2B, Cohorts 12-13 |
| PlaceboFor placebo product, the SRT3025 drug substance will be replaced by Microcrystalline Cellulose (Avicel® PH 105) to match the SRT3025 investigational product. | Drug | Part 1A, Cohorts 1-6, Part 2A, Cohorts 9-11 |
Primary outcome
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of a single dose of SRT3025 in healthy male subjects.
Time frame: 9 days
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of a single dose of SRT3025 in healthy male subjects.
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of multiple doses of SRT3025 in healthy male subjects.
Time frame: 21 days
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of multiple doses of SRT3025 in healthy male subjects.
6 secondary outcomes
Plasma levels of SRT3025 will be measured in all subjects that received a single dose of the study drug at fasted and fed states to assess the pharmacokinetics and bioavailability of SRT3025.
Time frame: 24 hours
Plasma levels of SRT3025 will be measured in all subjects that received multiple doses of the study drug at fasted and fed states to assess the pharmacokinetics and bioavailability of SRT3025.
Time frame: 14 days
SRT3025 metabolite levels in urine and plasma will be measured in all subjects that received a single dose of SRT3025.
Time frame: 24 hours
SRT3025 metabolite levels in urine and plasma will be measured in all subjects that received multiple dose of SRT3025.
Time frame: 15 days
Plasma levels of SRT3025 may be compared to the number and types of adverse events experienced by subjects receiving a single dose of SRT3025 to assess any relationship between plasma SRT3025 levels and adverse events.
Time frame: 9 days
Plasma levels of SRT3025 may be compared to the number and types of adverse events experienced by subjects receiving multiple doses of SRT3025 to assess any relationship between plasma SRT3025 levels and adverse events.
Time frame: 21 days
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 Oct 2017.
- Results for study 115444 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 SRT3025 in people with Diabetes Mellitus, Type 2, run by Sirtris, a GSK Company at 1 site in United Kingdom.
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 5 inclusion and 15 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 Oct 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 United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of a single dose of SRT3025 in healthy male subjects. (time frame: 9 days). 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 30 Oct 2017.