Healthy ParticipantsPhase 1NCT06745271
A Study to Determine How Tebapivat is Absorbed, Broken Down, and Removed From the Body and the Extent to Which Tebapivat is Made Available in the Body in Healthy Participants
A Phase 1 study testing [14C]-tebapivat and [13C2,15N3]-tebapivat in people with Healthy Participants, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the routes, rates of elimination, mass balance of total radioactivity and metabolite profiles following a single oral dose of [14C]-tebapivat. 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
- Healthy Participants
- What is being tested?
- [14C]-tebapivat and [13C2,15N3]-tebapivat
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2024to 21 Feb 2025
- 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
- Male, of any race, between 18 and 55 years of age, inclusive.
- Males must agree to use contraception.
- Body mass index between 18.0 and 30.0 kilograms per meter square (kg/m2), inclusive, and a body weight between 50 and 100 kilograms (kg), inclusive.
- In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in, and from the physical examination at check-in, as assessed by the investigator or designee.
- History of a minimum of 1 bowel movement per day.
- Able to comprehend and are willing to sign the informed consent form (ICF) and abide by the study restrictions.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed; cholecystectomy is not allowed).
- Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
- Administration of any vaccine within 30 days prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, and excretion (AME) processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
Show all 21Show fewer
- Use or intend to use any prescription medications/products within 14 days or 5 half-lives (whichever is longer) prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Use or intend to use any slow release medications/products considered to still be active within 14 days or 5 half-lives (whichever is longer) prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Participation in a clinical study involving administration of an IMP (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer.
- Have previously completed or withdrawn from this study or any other study investigating tebapivat and have previously received tebapivat.
- Participants who have previously been dosed in >1 radiolabeled drug study in the last 12 months. For participants who have previously been dosed in 1 radiolabeled drug study within the last 12 months, the previous radiolabeled dose must be at least 6 months prior to check-in at the clinical research unit (CRU). The total 12 month exposure from this study and a maximum of 1 other previous radiolabeled study must be within the Code of Federal Regulations (CFR) recommended levels considered safe, per United States (US) Title 21 CFR 361.1.
- Alcohol consumption of >21 units per week. One unit of alcohol equals 12 ounces (oz) (360 milliliters (mL)) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
- Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in.
- History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
- Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine at screening or check-in.
- Receipt of blood products within 2 months prior to check-in.
- Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- Poor peripheral venous access.
- Participants with exposure to significant diagnostic or therapeutic radiation (e.g., serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Participants who, in the opinion of the investigator or designee, should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label Study to Evaluate the Absorption, Metabolism, and Excretion and to Assess the Absolute Bioavailability Following a Single Oral Dose of [14C]-Tebapivat and Concomitant Single Intravenous Microdose of [13C2,15N3]-Tebapivat to Healthy Male Participants
The primary purpose of this study is to determine the routes, rates of elimination, mass balance of total radioactivity and metabolite profiles following a single oral dose of [14C]-tebapivat. To characterize the PK of tebapivat and [13C2,15N3]-tebapivat and determine the absolute bioavailability following single oral dose of [14C]-tebapivat relative to single intravenous microdose of [13C2,15N3]-tebapivat to healthy male participants.
- Conditions
- Healthy Participants
- Being tested
- [14C]-tebapivat, [13C2,15N3]-tebapivat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-tebapivatDrug
Oral Capsule
[13C2,15N3]-tebapivatDrug
Intravenous Solution
| Study group | Role | What they receive |
|---|---|---|
| [14C]-tebapivat and [13C2,15N3]-tebapivat | Experimental | Participants will receive a single oral dose of 10 milligrams (mg) [14C]-tebapivat containing 200 microcurie [μCi] of radiocarbon in a capsule followed by a single intravenous (IV) microdose of 0.1 mg [13C2,15N3]-tebapivat on Day 1. Receives: Drug: [14C]-tebapivat; Drug: [13C2,15N3]-tebapivat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Radioactive Dose Excreted in Urine Over a Time Interval (feut1-t2) of [14C]-Tebapivat
Measured: Up to Day 42
Percentage of Radioactive Dose Excreted in Feces Over a Time Interval (fef t1-t2) of [14C]-Tebapivat
Measured: Up to Day 42
Cumulative Percentage of Radioactive Dose Excreted in Urine Over a Time Interval (Cum feut1-t2) of [14C]-Tebapivat
Measured: Up to Day 42
Cumulative Percentage of Radioactive Dose Excreted in Feces Over a Time Interval (Cum fef t1-t2) of [14C]-Tebapivat
Measured: Up to Day 42
Percentage of Total Radioactivity in Total Excreta (Feces + Urine) (Cum fe) of [14C]-Tebapivat
Measured: Up to Day 42
Amount of Drug Excreted in Urine (Aeu) of [14C]-Tebapivat
Measured: Up to Day 42
Cumulative Amount of Drug Excreted in Urine (Cum Aeu) of [14C]-Tebapivat
Measured: Up to Day 42
Renal Clearance (CLR) of [14C]-Tebapivat
Measured: Up to Day 42
Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hours Postdose (AUC0-168) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Measured: Up to Day 7
AUC0-168 in Plasma and Whole Blood for Total Radioactivity
Measured: Up to Day 7
AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Measured: Up to Day 21
AUC0-t in Plasma and Whole Blood for Total Radioactivity
Measured: Up to Day 42
AUC Extrapolated to Infinity (AUC0-inf) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Measured: Up to Day 21
(AUC0-inf) in Plasma and Whole Blood for Total Radioactivity
Measured: Up to Day 42
Maximum Observed Plasma Concentration (Cmax) for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Measured: Up to Day 21
Cmax in Plasma and Whole Blood for Total Radioactivity
Measured: Up to Day 42
Time to Reach Cmax (Tmax) for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Measured: Up to Day 21
Tmax in Plasma and Whole Blood for Total Radioactivity
Measured: Up to Day 42
Terminal Elimination Half-Life (t1/2) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Measured: Up to Day 21
T1/2 in Plasma and Whole Blood for Total Radioactivity
Measured: Up to Day 42
Ratio of AUC0-inf for Tebapivat to AUC0-inf for Total Radioactivity in Plasma
Measured: Up to Day 42
Ratio of AUC0-inf for Total Radioactivity in Whole Blood to AUC0-inf for Total Radioactivity in Plasma
Measured: Up to Day 42
Total Clearance Following IV Administration (CL) of [13C2,15N3]-Tebapivat
Measured: Up to Day 21
Apparent Volume of Distribution During the Terminal Phase Following IV Administration (Vz) of [13C2,15N3]-Tebapivat
Measured: Up to Day 21
Apparent Volume of Distribution at Steady State Following IV Administration (Vss) of [13C2,15N3]-Tebapivat
Measured: Up to Day 21
Ratio of Dose-Normalized AUC0-inf of Oral Administration of [14C]-Tebapivat Relative to IV Administration of [13C2,15N3]-Tebapivat
Measured: Up to Day 21
Quantitation of Major Metabolites of [14C]-Tebapivat in Plasma After Oral Administration
Quantification of major metabolites of [14C]-tebapivat in plasma.
Measured: Up to Day 21
Quantitation of Major Metabolites of [14C]-Tebapivat in Excreta After Oral Administration
Quantification of major metabolites of [14C]-tebapivat in excreta.
Measured: Up to Day 42
Identification of Chemical Structure of Major Metabolites of [14C]-Tebapivat in Plasma After Oral Administration
Identification of the chemical structures of major metabolites of [14C]-tebapivat in plasma.
Measured: Up to Day 21
Identification of Chemical Structure of Major Metabolites of [14C]-Tebapivat in Excreta After Oral Administration
Identification of the chemical structures of major metabolites of [14C]-tebapivat in excreta.
Measured: Up to Day 42
Secondary outcomes (4)
Number of Participants with Adverse Events (AEs) by Type, Severity, and Relationship to Study Drug
Measured: Up to Day 28
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Assessments
Measured: Baseline up to Day 28
Number of Participants With Clinically Significant Change From Baseline in Abnormal 12-Lead Electrocardiogram (ECG) Parameters
Measured: Baseline up to Day 28
Number of Participants With Clinically Significant Change From Baseline in Abnormal Vital Signs Measurements
Measured: Baseline up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start20 Dec 2024
- Primary completion21 Feb 2025
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745271
- Sponsor's protocol ID
- AG946-C-004
- Status last verified
- Mar 2025
- First submitted
- 17 Dec 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study to Evaluate the Absorption, Metabolism, and Excretion and to Assess the Absolute Bioavailability Following a Single Oral Dose of [14C]-Tebapivat and Concomitant Single Intravenous Microdose of [13C2,15N3]-Tebapivat to Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06745271
- Acronym / sponsor ID
- AG946-C-004
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 20 Dec 2024 (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.
The primary purpose of this study is to determine the routes, rates of elimination, mass balance of total radioactivity and metabolite profiles following a single oral dose of [14C]-tebapivat. To characterize the PK of tebapivat and [13C2,15N3]-tebapivat and determine the absolute bioavailability following single oral dose of [14C]-tebapivat relative to single intravenous microdose of [13C2,15N3]-tebapivat to healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-tebapivat and [13C2,15N3]-tebapivat | Experimental | Drug: [14C]-tebapivat, Drug: [13C2,15N3]-tebapivatParticipants will receive a single oral dose of 10 milligrams (mg) [14C]-tebapivat containing 200 microcurie [μCi] of radiocarbon in a capsule followed by a single intravenous (IV) microdose of 0.1 mg [13C2,15N3]-tebapivat on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male, of any race, between 18 and 55 years of age, inclusive.
- Body mass index between 18.0 and 30.0 kilograms per meter square (kg/m2), inclusive, and a body weight between 50 and 100 kilograms (kg), inclusive.
- In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in, and from the physical examination at check-in, as assessed by the investigator or designee.
- History of a minimum of 1 bowel movement per day.
- Able to comprehend and are willing to sign the informed consent form (ICF) and abide by the study restrictions.
Key exclusion criteria (21 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed; cholecystectomy is not allowed).
- Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
- Administration of any vaccine within 30 days prior to dosing.
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]-tebapivatOral Capsule | Drug | [14C]-tebapivat and [13C2,15N3]-tebapivat |
| [13C2,15N3]-tebapivatIntravenous Solution | Drug | [14C]-tebapivat and [13C2,15N3]-tebapivat |
Primary outcome
Percentage of Radioactive Dose Excreted in Urine Over a Time Interval (feut1-t2) of [14C]-Tebapivat
Time frame: Up to Day 42
Percentage of Radioactive Dose Excreted in Feces Over a Time Interval (fef t1-t2) of [14C]-Tebapivat
Time frame: Up to Day 42
Cumulative Percentage of Radioactive Dose Excreted in Urine Over a Time Interval (Cum feut1-t2) of [14C]-Tebapivat
Time frame: Up to Day 42
Cumulative Percentage of Radioactive Dose Excreted in Feces Over a Time Interval (Cum fef t1-t2) of [14C]-Tebapivat
Time frame: Up to Day 42
Percentage of Total Radioactivity in Total Excreta (Feces + Urine) (Cum fe) of [14C]-Tebapivat
Time frame: Up to Day 42
Amount of Drug Excreted in Urine (Aeu) of [14C]-Tebapivat
Time frame: Up to Day 42
Cumulative Amount of Drug Excreted in Urine (Cum Aeu) of [14C]-Tebapivat
Time frame: Up to Day 42
Renal Clearance (CLR) of [14C]-Tebapivat
Time frame: Up to Day 42
Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hours Postdose (AUC0-168) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Time frame: Up to Day 7
AUC0-168 in Plasma and Whole Blood for Total Radioactivity
Time frame: Up to Day 7
AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Time frame: Up to Day 21
AUC0-t in Plasma and Whole Blood for Total Radioactivity
Time frame: Up to Day 42
AUC Extrapolated to Infinity (AUC0-inf) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Time frame: Up to Day 21
(AUC0-inf) in Plasma and Whole Blood for Total Radioactivity
Time frame: Up to Day 42
Maximum Observed Plasma Concentration (Cmax) for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Time frame: Up to Day 21
Cmax in Plasma and Whole Blood for Total Radioactivity
Time frame: Up to Day 42
Time to Reach Cmax (Tmax) for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Time frame: Up to Day 21
Tmax in Plasma and Whole Blood for Total Radioactivity
Time frame: Up to Day 42
Terminal Elimination Half-Life (t1/2) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Time frame: Up to Day 21
T1/2 in Plasma and Whole Blood for Total Radioactivity
Time frame: Up to Day 42
Ratio of AUC0-inf for Tebapivat to AUC0-inf for Total Radioactivity in Plasma
Time frame: Up to Day 42
Ratio of AUC0-inf for Total Radioactivity in Whole Blood to AUC0-inf for Total Radioactivity in Plasma
Time frame: Up to Day 42
Total Clearance Following IV Administration (CL) of [13C2,15N3]-Tebapivat
Time frame: Up to Day 21
Apparent Volume of Distribution During the Terminal Phase Following IV Administration (Vz) of [13C2,15N3]-Tebapivat
Time frame: Up to Day 21
Apparent Volume of Distribution at Steady State Following IV Administration (Vss) of [13C2,15N3]-Tebapivat
Time frame: Up to Day 21
Ratio of Dose-Normalized AUC0-inf of Oral Administration of [14C]-Tebapivat Relative to IV Administration of [13C2,15N3]-Tebapivat
Time frame: Up to Day 21
Quantitation of Major Metabolites of [14C]-Tebapivat in Plasma After Oral Administration
Time frame: Up to Day 21
Quantification of major metabolites of [14C]-tebapivat in plasma.
Quantitation of Major Metabolites of [14C]-Tebapivat in Excreta After Oral Administration
Time frame: Up to Day 42
Quantification of major metabolites of [14C]-tebapivat in excreta.
Identification of Chemical Structure of Major Metabolites of [14C]-Tebapivat in Plasma After Oral Administration
Time frame: Up to Day 21
Identification of the chemical structures of major metabolites of [14C]-tebapivat in plasma.
Identification of Chemical Structure of Major Metabolites of [14C]-Tebapivat in Excreta After Oral Administration
Time frame: Up to Day 42
Identification of the chemical structures of major metabolites of [14C]-tebapivat in excreta.
4 secondary outcomes
Number of Participants with Adverse Events (AEs) by Type, Severity, and Relationship to Study Drug
Time frame: Up to Day 28
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Assessments
Time frame: Baseline up to Day 28
Number of Participants With Clinically Significant Change From Baseline in Abnormal 12-Lead Electrocardiogram (ECG) Parameters
Time frame: Baseline up to Day 28
Number of Participants With Clinically Significant Change From Baseline in Abnormal Vital Signs Measurements
Time frame: Baseline up to Day 28
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 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-tebapivat and [13C2,15N3]-tebapivat in people with Healthy Participants, run by Agios Pharmaceuticals, Inc. 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 6 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 18 Mar 2025. 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. 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?
Percentage of Radioactive Dose Excreted in Urine Over a Time Interval (feut1-t2) of [14C]-Tebapivat (time frame: Up to Day 42). The study lists 30 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 18 Mar 2025.