Healthy VolunteerPhase 1NCT04495140

Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961

A Phase 1 study testing [14C]PF-06882961, 50 mg and PF-06882961, 50 mg and [14C]PF-06882961, 100 ug in people with Healthy Volunteer, run by Pfizer at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a Phase 1, open-label, non-randomized, 2-period, fixed sequence study to characterize the metabolic profile and routes of excretion of oral [14C]PF-06882961 and to evaluate the absolute oral bioavailability of PF-06882961 and fraction absorbed of [14C]PF-06882961 in reference to intravenous… Read more about this study

Who is it for?: Ages 18 to 54 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: [14C]PF-06882961, 50 mg and PF-06882961, 50 mg and [14C]PF-06882961, 100 ug
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 2 sitesNetherlands
Study dates: 22 Jul 2020to 15 Oct 2020
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 54 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male participants between 18 to 54 years of age
Healthy and capable of signing informed consent document
Willing to comply to all scheduled visits, lab tests, lifestyle considerations and study procedures
Body mass index (BMI) of 17.5 to 30 kg/m2; and a total body weight ≥50 kg (110 lb).

Who cannot join

acute or chronic medical or psychiatric condition including recent (within the past year)
Surgical procedures like gastrectomy, cholecystectomy, Irregularity in bowel movements
Use of prescription or non-prescription drugs and dietary and herbal supplements within 14 days prior to the first dose of investigational product.
Previous administration with an investigational drug within 60 days (or as determined by the local requirement) preceding the first dose of investigational product used in this study.
Known prior participation in a trial involving PF-06882961 or known intolerance to a GLP-1R agonist.
A positive urine drug test on screening or Day -1.

Show all 14Show fewer

Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
Participants with abnormalities in clinical laboratory tests including ECGs, vital signs, liver function tests, myocardial infarction
Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
History of alcohol or tobacco abuse or binge drinking and/or any other illicit drug use or dependence within past 6 months.
Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
History of sensitivity to heparin or heparin-induced thrombocytopenia only if heparin is planned to flush intravenous catheters.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

PRA Health Sciences
Groningen, 9728 NZ
PRA Health Sciences Utrecht
Utrecht, 3584 BL

Other trials in Netherlands

About this study

Official title: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06882961

Conditions: Healthy Volunteer
Being tested: [14C]PF-06882961, 50 mg, PF-06882961, 50 mg and [14C]PF-06882961, 100 ug
Keywords: bioavailability, excretion, metabolism, absorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[14C]PF-06882961, 50 mgDrug
A single oral dose of [14C]PF-06882961, will be administered as a liquid formulation.
PF-06882961, 50 mg and [14C]PF-06882961, 100 ugDrug
A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961 will be administered via intravenous infusion.

Study groups in NCT04495140
Study group	Role	What they receive
Oral [14C]PF-06882961, 50 mg	Experimental	In this arm, a single oral dose of [14C]PF-06882961, 50 mg will be administered as a liquid formulation. Receives: Drug: [14C]PF-06882961, 50 mg
Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug	Experimental	In this arm, single oral dose of unlabeled PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961, 100 ug, will be administered via intravenous infusion. Receives: Drug: PF-06882961, 50 mg and [14C]PF-06882961, 100 ug

What is being measured

The primary outcome is the main question the study is designed to answer.

Total recovery of radioactivity in urine and feces, following oral administration of [14C] PF-06882961 in period 1
Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered.
Measured: Baseline through approximately hour 312 (day 14). Period 1 is 14 days

Secondary outcomes (20)

Metabolite profiling/identification in plasma, urine, and feces
Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C]PF-06882961 in plasma, urine, and feces.
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312 hour (hr)
Plasma Cmax to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
Maximum Observed Plasma Radioactivity
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma Tmax to describe the PK of total radioactivity following administration of single, oral dose of [14C]PF-06882961
Time to Reach Maximum Observed Plasma Radioactivity
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma AUClast to describe PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
Area under the plasma radioactivity-time profile from time 0 to time of the last quantifiable concentration (Clast)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma AUCinf to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma elimination t½ to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.
Measured: 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma Cmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
Maximum Observed Plasma Concentration
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma Tmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C]PF-06882961
Time to Reach Maximum Observed Plasma Concentration
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma AUClast to describe PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
Area under the plasma concentration-time profile from time 0 to time of the last quantifiable concentration (Clast)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma AUCinf to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
AUCinf is Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Mean residence Time (MRT )following administration of a single, intravenous dose of [14C]PF 06882961
where MRT is the Mean Residence Time
Measured: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
Systemic Clearance (CL) following administration of a single, intravenous dose of [14C]PF 06882961
Systemic clearance, CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
Volume of distribution at steady state (Vss) following administration of a single, intravenous dose of [14C]PF 06882961
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Measured: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
Absolute oral bioavailability (F)
Absolute oral bioavailability following administration of a single oral dose of PF-06882961 in reference to a single intravenous dose of [14C]PF-06882961
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Fraction of dose absorbed following single oral administration of [14C]PF-06882961
Fraction absorbed calculated from ratio of total urinary radioactivity following oral administration in reference to intravenous administration
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312hr
Number of participants with adverse events
adverse events
Measured: Baseline in Period 1 up to 32 days after the period 2 doses, for a total of approximately 46 days
Plasma elimination t½ to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.
Measured: 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Number of participants with safety laboratory test results above/below certain threshold
lab tests
Measured: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
Number of participants with ECG measurements above/below certain threshold
ECGs
Measured: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
Number of participants with vital measurements above/below certain threshold
vitals
Measured: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 202015 Oct 2020

First posted31 Jul 2020
Study start22 Jul 2020
Primary completion15 Oct 2020
Study completion15 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04495140
Sponsor's protocol ID: C3421009
Other IDs: 2019-002584-10, 2019
Status last verified: Nov 2020
First submitted: 16 Jul 2020
Last updated: 25 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06882961
ClinicalTrials.gov ID: NCT04495140
Acronym / sponsor ID: C3421009
Conditions: Healthy Volunteer
Keywords: bioavailability, excretion, metabolism, absorption
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 22 Jul 2020 (actual)
Primary completion: 15 Oct 2020 (actual)
Study completion: 15 Oct 2020 (actual)
First posted: 31 Jul 2020 (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.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Oral [14C]PF-06882961, 50 mg	Experimental	Drug: [14C]PF-06882961, 50 mgIn this arm, a single oral dose of [14C]PF-06882961, 50 mg will be administered as a liquid formulation.
Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug	Experimental	Drug: PF-06882961, 50 mg and [14C]PF-06882961, 100 ugIn this arm, single oral dose of unlabeled PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961, 100 ug, will be administered via intravenous infusion.

Who may qualify

Ages: 18 to 54 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Male participants between 18 to 54 years of age
Healthy and capable of signing informed consent document
Willing to comply to all scheduled visits, lab tests, lifestyle considerations and study procedures
Body mass index (BMI) of 17.5 to 30 kg/m2; and a total body weight ≥50 kg (110 lb).

Key exclusion criteria (14 listed)

acute or chronic medical or psychiatric condition including recent (within the past year)
Surgical procedures like gastrectomy, cholecystectomy, Irregularity in bowel movements
Use of prescription or non-prescription drugs and dietary and herbal supplements within 14 days prior to the first dose of investigational product.
Previous administration with an investigational drug within 60 days (or as determined by the local requirement) preceding the first dose of investigational product used in this study.
Known prior participation in a trial involving PF-06882961 or known intolerance to a GLP-1R agonist.

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
[14C]PF-06882961, 50 mgA single oral dose of [14C]PF-06882961, will be administered as a liquid formulation.	Drug	Oral [14C]PF-06882961, 50 mg
PF-06882961, 50 mg and [14C]PF-06882961, 100 ugA single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961 will be administered via intravenous infusion.	Drug	Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug

Primary outcome

Total recovery of radioactivity in urine and feces, following oral administration of [14C] PF-06882961 in period 1
Time frame: Baseline through approximately hour 312 (day 14). Period 1 is 14 days
Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered.

20 secondary outcomes

Metabolite profiling/identification in plasma, urine, and feces
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312 hour (hr)
Plasma Cmax to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma Tmax to describe the PK of total radioactivity following administration of single, oral dose of [14C]PF-06882961
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma AUClast to describe PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma AUCinf to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma elimination t½ to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
Time frame: 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma Cmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma Tmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C]PF-06882961
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma AUClast to describe PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma AUCinf to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Mean residence Time (MRT )following administration of a single, intravenous dose of [14C]PF 06882961
Time frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
Systemic Clearance (CL) following administration of a single, intravenous dose of [14C]PF 06882961
Time frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
Volume of distribution at steady state (Vss) following administration of a single, intravenous dose of [14C]PF 06882961
Time frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
Absolute oral bioavailability (F)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Fraction of dose absorbed following single oral administration of [14C]PF-06882961
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312hr
Number of participants with adverse events
Time frame: Baseline in Period 1 up to 32 days after the period 2 doses, for a total of approximately 46 days
Plasma elimination t½ to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
Time frame: 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Number of participants with safety laboratory test results above/below certain threshold
Time frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
Number of participants with ECG measurements above/below certain threshold
Time frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
Number of participants with vital measurements above/below certain threshold
Time frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 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 25 Nov 2020.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]PF-06882961, 50 mg and PF-06882961, 50 mg and [14C]PF-06882961, 100 ug in people with Healthy Volunteer, run by Pfizer at 2 sites in Netherlands.

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 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. 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?

Total recovery of radioactivity in urine and feces, following oral administration of [14C] PF-06882961 in period 1 (time frame: Baseline through approximately hour 312 (day 14). Period 1 is 14 days). 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 NCT04495140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.