Healthy VolunteerPhase 1NCT07773129
A Study to Learn How ASP3082 is Processed in Healthy Men
A Phase 1 study testing 14C-labeled ASP3082 in people with Healthy Volunteer, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
Setidegrasib (ASP3082) is being developed for certain cancers. In this study, the researchers want to understand how it is processed by the body in healthy male volunteers. To do this, [14C] which is a certain chemical (called a tracer, or radionuclide) has been added to setidegrasib. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- 14C-labeled ASP3082
- Type of treatment
- 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
- 28 Aug 2026to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is healthy and has no clinically significant medical conditions based on the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.
- Participant has regular bowel habits (i.e., at least 1 bowel movement per day).
- Male participant:
- Must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the investigational period and for 3 months after study intervention administration.
- Must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 3 months after study intervention administration.
- Must not donate sperm during the investigational period and for 3 months after investigational study intervention administration.
- Participant agrees not to participate in another interventional study while participating in the present study.
- Participant has a body mass index (BMI) range of 18.0 to 32.0 kg/m^2, inclusive and weighs at least 50 kg at screening.
Who cannot join
- Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease.
- Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence).
- Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives (approximately 8 to 9 days) after the dose of study drug administration or end-of-study visit (ESV), whichever is longer.
- Participant has previously undergone a cholecystectomy.
- Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day -1.
- Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 2 years before screening.
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- Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.
- Participant has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John's Wort) in the 28 days prior to day -1, except for occasional use of acetaminophen (up to 2 g/day) and topical dermatological products (including corticosteroid products).
- Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 28 days prior to day -1.
- Participant has received a coronavirus disease 2019 (COVID-19) vaccine within the 14 days prior to day -1 or will have a COVID-19 vaccine dose before the ESV.
- Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Participant has participated in more than 2 radiolabeled studies within 12 months prior to day -1 (participation in a previous radiolabeled study has to have been at least 4 months prior to day -1 where exposures are known to the investigator, or 6 months prior to day -1 where exposures are not known to the investigator).
- Participant has any liver test result (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and total bilirubin [TBL]) ≥ 1.5 × upper limit of normal (ULN) on day -1.
- Participant has clinically significant creatinine elevation.
- Participant has any of the following conditions on day -1 or predose: mean pulse < 40 or > 90 bpm; mean systolic blood pressure (SBP) > 140 mmHg; mean diastolic blood pressure (DBP) > 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse measured automatically). If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
- Participant has a mean corrected QT interval by Fridericia (QTcF) of > 450 msec on day -1.
- Participant tests positive for alcohol at screening or on day -1.
- Participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) at screening or on day -1.
- Participant tests positive for cannabinoids on day -1.
- Participant has a positive serology test for hepatitis A virus (HAV) antibodies immunoglobulin M (IgM), hepatitis B (HBc) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening.
- Participant has any condition, that makes the participant unsuitable for study participation.
- Participant has 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 day -1.
- Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.
- Participant has a history of smoking > 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1 or the participant tests positive for cotinine at screening or day -1.
- Participant has a history of consuming > 10 units of alcoholic beverages per week within 3 months prior to screening (Note: 1 unit = 12 ounces of beer, 5 ounces of wine, 1.5 ounce of spirits/hard liquor).
- Participant has used any drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine and/or opiates) within 3 months prior to day -1.
- Participant has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days prior to day -1.
- Participant has had previous exposure with ASP3082.
- Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fortrea Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Metabolism and Excretion of [14C]ASP3082 in Healthy Adult Male Participants
Setidegrasib (ASP3082) is being developed for certain cancers. In this study, the researchers want to understand how it is processed by the body in healthy male volunteers.
To do this, [14C] which is a certain chemical (called a tracer, or radionuclide) has been added to setidegrasib. [14C] gives off radiation, but the dose is very low (about the same as the dose from an x-ray) and will leave the body within a few days. [14C] will be picked up by a scanner and will be used to follow setidegrasib through the body. [14C]setidegrasib will be given as 1 single injection slowly through a vein (infusion).
The men will stay overnight in the clinic for at least 2 weeks. They will give regular blood, urine and stool samples during their stay and will be closely monitored. The men will return to the clinic about 1 week later for a final safety check.
- Conditions
- Healthy Volunteer
- Being tested
- 14C-labeled ASP3082
- Keywords
- ASP3082, Setidegrasib, Pharmacokinetics, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-labeled ASP3082Drug
Also called Setidegrasib
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 14C-labeled ASP3082 | Experimental | Participants will receive single dose of 14C-labeled ASP3082 on Day 1. Receives: Drug: 14C-labeled ASP3082 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of 14C-labeled ASP3082 (radioactivity in whole blood): area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the PK whole blood samples collected.
Measured: Up to 21 days
PK of 14C-labeled ASP3082 (radioactivity in whole blood): area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
AUClast will be recorded from the PK whole blood samples collected.
Measured: Up to 21 days
PK of 14C-labeled ASP3082 (radioactivity in whole blood): maximum concentration (Cmax)
Cmax will be recorded from the PK whole blood samples collected.
Measured: Up to 21 days
PK of 14C-labeled ASP3082 (radioactivity in plasma): AUCinf
AUCinf will be recorded from the PK plasma samples collected.
Measured: Up to 21 days
PK of 14C-labeled ASP3082 (radioactivity in plasma): AUClast
AUClast will be recorded from the PK plasma samples collected.
Measured: Up to 21 days
PK of 14C-labeled ASP3082 (radioactivity in plasma): Cmax
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to 21 days
PK of 14C-labeled ASP3082 (radioactivity ratio of whole blood/plasma concentrations): radioactivity ratio of area under the concentration time curve in blood as compared to plasma (AUCblood/AUCplasma)
AUCblood/AUCplasma will be recorded from PK whole blood and plasma samples collected.
Measured: Up to 21 days
Excretion of 14C-labeled ASP3082 (radioactivity in urine): amount of administered dose excreted (Ae)
Ae will be recorded from urine samples collected.
Measured: Up to 21 days
Excretion of 14C-labeled ASP3082 (radioactivity in urine): percentage of administered dose excreted (Ae percentage)
Ae percentage will be recorded from urine samples collected.
Measured: Up to 21 days
Excretion of 14C-labeled ASP3082 (radioactivity in urine): cumulative (over more than 1 sampling interval) amount of administered dose excreted (CumAe)
CumAe will be recorded from urine samples collected.
Measured: Up to 21 days
Excretion of 14C-labeled ASP3082 (radioactivity in urine): renal clearance (CLr)
CLr will be recorded from urine samples collected.
Measured: Up to 21 days
Excretion of 14C-labeled ASP3082 (radioactivity in feces): Ae
Ae will be recorded from feces samples collected.
Measured: Up to 21 days
Excretion of 14C-labeled ASP3082 (radioactivity in feces): Ae percentage
Ae percentage will be recorded from feces samples collected.
Measured: Up to 21 days
Excretion of 14C-labeled ASP3082 (radioactivity in feces): CumAe
CumAe will be recorded from feces samples collected.
Measured: Up to 21 days
Excretion of 14C-labeled ASP3082 (combined radioactivity in urine and feces): Ae
Combined Ae will be recorded from urine and feces samples collected.
Measured: Up to 21 days
Excretion of 14C-labeled ASP3082 (combined radioactivity in urine and feces): Ae percentage
Combined Ae percentage will be recorded from urine and feces samples collected.
Measured: Up to 21 days
Excretion of 14C-labeled ASP3082 (combined radioactivity in urine and feces): CumAe
Combined CumAe will be recorded from urine and feces samples collected.
Measured: Up to 21 days
Secondary outcomes (7)
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Measured: Up to 30 days
Number of Participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 30 days
Number of Participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 30 days
Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Measured: Up to 30 days
Metabolite identification of ASP3082 in plasma
Identification of metabolites in plasma.
Measured: Up to 21 days
Metabolite identification of ASP3082 in urine
Identification of metabolites in urine.
Measured: Up to 21 days
Metabolite identification of ASP3082 in feces
Identification of metabolites in feces.
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start28 Aug 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
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 Astellas Pharma Global Development, Inc.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773129
- Sponsor's protocol ID
- 3082-CL-0103
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Metabolism and Excretion of [14C]ASP3082 in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT07773129
- Acronym / sponsor ID
- 3082-CL-0103
- Conditions
- Healthy Volunteer
- Keywords
- ASP3082, Setidegrasib, Pharmacokinetics, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 19 Aug 2026 (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.
Setidegrasib (ASP3082) is being developed for certain cancers. In this study, the researchers want to understand how it is processed by the body in healthy male volunteers.
To do this, [14C] which is a certain chemical (called a tracer, or radionuclide) has been added to setidegrasib. [14C] gives off radiation, but the dose is very low (about the same as the dose from an x-ray) and will leave the body within a few days. [14C] will be picked up by a scanner and will be used to follow setidegrasib through the body. [14C]setidegrasib will be given as 1 single injection slowly through a vein (infusion).
The men will stay overnight in the clinic for at least 2 weeks. They will give regular blood, urine and stool samples during their stay and will be closely monitored. The men will return to the clinic about 1 week later for a final safety check.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-labeled ASP3082 | Experimental | Drug: 14C-labeled ASP3082Participants will receive single dose of 14C-labeled ASP3082 on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant is healthy and has no clinically significant medical conditions based on the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.
- Participant has regular bowel habits (i.e., at least 1 bowel movement per day).
- Male participant:
- Participant agrees not to participate in another interventional study while participating in the present study.
- Participant has a body mass index (BMI) range of 18.0 to 32.0 kg/m^2, inclusive and weighs at least 50 kg at screening.
Key exclusion criteria (29 listed)
- Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease.
- Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence).
- Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives (approximately 8 to 9 days) after the dose of study drug administration or end-of-study visit (ESV), whichever is longer.
- Participant has previously undergone a cholecystectomy.
- Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day -1.
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-labeled ASP3082Also: SetidegrasibIntravenous infusion | Drug | 14C-labeled ASP3082 |
Primary outcome
Pharmacokinetics (PK) of 14C-labeled ASP3082 (radioactivity in whole blood): area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: Up to 21 days
AUCinf will be recorded from the PK whole blood samples collected.
PK of 14C-labeled ASP3082 (radioactivity in whole blood): area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Time frame: Up to 21 days
AUClast will be recorded from the PK whole blood samples collected.
PK of 14C-labeled ASP3082 (radioactivity in whole blood): maximum concentration (Cmax)
Time frame: Up to 21 days
Cmax will be recorded from the PK whole blood samples collected.
PK of 14C-labeled ASP3082 (radioactivity in plasma): AUCinf
Time frame: Up to 21 days
AUCinf will be recorded from the PK plasma samples collected.
PK of 14C-labeled ASP3082 (radioactivity in plasma): AUClast
Time frame: Up to 21 days
AUClast will be recorded from the PK plasma samples collected.
PK of 14C-labeled ASP3082 (radioactivity in plasma): Cmax
Time frame: Up to 21 days
Cmax will be recorded from the PK plasma samples collected.
PK of 14C-labeled ASP3082 (radioactivity ratio of whole blood/plasma concentrations): radioactivity ratio of area under the concentration time curve in blood as compared to plasma (AUCblood/AUCplasma)
Time frame: Up to 21 days
AUCblood/AUCplasma will be recorded from PK whole blood and plasma samples collected.
Excretion of 14C-labeled ASP3082 (radioactivity in urine): amount of administered dose excreted (Ae)
Time frame: Up to 21 days
Ae will be recorded from urine samples collected.
Excretion of 14C-labeled ASP3082 (radioactivity in urine): percentage of administered dose excreted (Ae percentage)
Time frame: Up to 21 days
Ae percentage will be recorded from urine samples collected.
Excretion of 14C-labeled ASP3082 (radioactivity in urine): cumulative (over more than 1 sampling interval) amount of administered dose excreted (CumAe)
Time frame: Up to 21 days
CumAe will be recorded from urine samples collected.
Excretion of 14C-labeled ASP3082 (radioactivity in urine): renal clearance (CLr)
Time frame: Up to 21 days
CLr will be recorded from urine samples collected.
Excretion of 14C-labeled ASP3082 (radioactivity in feces): Ae
Time frame: Up to 21 days
Ae will be recorded from feces samples collected.
Excretion of 14C-labeled ASP3082 (radioactivity in feces): Ae percentage
Time frame: Up to 21 days
Ae percentage will be recorded from feces samples collected.
Excretion of 14C-labeled ASP3082 (radioactivity in feces): CumAe
Time frame: Up to 21 days
CumAe will be recorded from feces samples collected.
Excretion of 14C-labeled ASP3082 (combined radioactivity in urine and feces): Ae
Time frame: Up to 21 days
Combined Ae will be recorded from urine and feces samples collected.
Excretion of 14C-labeled ASP3082 (combined radioactivity in urine and feces): Ae percentage
Time frame: Up to 21 days
Combined Ae percentage will be recorded from urine and feces samples collected.
Excretion of 14C-labeled ASP3082 (combined radioactivity in urine and feces): CumAe
Time frame: Up to 21 days
Combined CumAe will be recorded from urine and feces samples collected.
7 secondary outcomes
Number of Participants with Adverse Events (AEs)
Time frame: Up to 30 days
Number of Participants with laboratory value abnormalities and/or AEs
Time frame: Up to 30 days
Number of Participants with vital sign abnormalities and/or AEs
Time frame: Up to 30 days
Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to 30 days
Metabolite identification of ASP3082 in plasma
Time frame: Up to 21 days
Metabolite identification of ASP3082 in urine
Time frame: Up to 21 days
Metabolite identification of ASP3082 in feces
Time frame: Up to 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Director study director
Astellas Pharma Global Development, Inc.
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-labeled ASP3082 in people with Healthy Volunteer, run by Astellas Pharma Global Development, 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 8 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Astellas Pharma Global Development, Inc. (800-888-7704, astellas.registration@astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) of 14C-labeled ASP3082 (radioactivity in whole blood): area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf) (time frame: Up to 21 days). The study lists 17 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 7 Oct 2026.