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CompletedNCT07773129Updated Nov 3, 2026

A Study to Learn How ASP3082 is Processed in Healthy Men

A Phase 1 interventional study of 14C-labeled ASP3082 in Healthy Volunteer, sponsored by Astellas Pharma Global Development, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Astellas Pharma Global Development, Inc. (part of Astellas Pharma Inc) · Phase 1, Interventional, and Basic science

Updated Nov 3, 2026Now CompletedNow Recruiting+7 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Male
01

Study 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. [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.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • ASP3082
  • Setidegrasib
  • Pharmacokinetics
  • Healthy Volunteers
03

In context

Lead sponsor

Astellas Pharma Global Development, Inc. is the lead sponsor of 207 studies on the registry; 23 are open to participants now.

Of its 82 completed or terminated interventional studies of FDA-regulated products, 38 (46%) have results posted.

Browse Astellas Pharma Global Development, Inc. studies →All Astellas Pharma Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 7, 2026. See what changed

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant is healthy and has no medical conditions based on the physical examination, (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 with female partner(s) of (including breastfeeding partner) throughout the 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 (BMI) range of 18.0 to 32.0 kg/m\^2, inclusive and weighs at least 50 kg at screening.

Exclusion criteria

Exclusion Criteria:

  • Participant has any history or evidence of any cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease.
  • Participant has a history of 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 (5th edition) (DSM-5) criteria within 2 years before screening.
  • 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 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 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 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], [ALT], aspartate aminotransferase [AST] and total [TBL]) ≥ 1.5 × (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), (HBc) antibodies, hepatitis B surface antigen (HBsAg), virus (HCV) antibodies or antibodies to (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 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.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    14C-labeled ASP3082

    Participants will receive single dose of 14C-labeled ASP3082 on Day 1.

    Drug: 14C-labeled ASP3082

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 21 days

  2. 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.

    Time frame: Up to 21 days

  3. PK of 14C-labeled ASP3082 (radioactivity in whole blood): maximum concentration (Cmax)

    Cmax will be recorded from the PK whole blood samples collected.

    Time frame: Up to 21 days

  4. PK of 14C-labeled ASP3082 (radioactivity in plasma): AUCinf

    AUCinf will be recorded from the PK plasma samples collected.

    Time frame: Up to 21 days

  5. PK of 14C-labeled ASP3082 (radioactivity in plasma): AUClast

    AUClast will be recorded from the PK plasma samples collected.

    Time frame: Up to 21 days

  6. PK of 14C-labeled ASP3082 (radioactivity in plasma): Cmax

    Cmax will be recorded from the PK plasma samples collected.

    Time frame: Up to 21 days

  7. 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.

    Time frame: Up to 21 days

  8. Excretion of 14C-labeled ASP3082 (radioactivity in urine): amount of administered dose excreted (Ae)

    Ae will be recorded from urine samples collected.

    Time frame: Up to 21 days

  9. Excretion of 14C-labeled ASP3082 (radioactivity in urine): percentage of administered dose excreted (Ae percentage)

    Ae percentage will be recorded from urine samples collected.

    Time frame: Up to 21 days

  10. 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.

    Time frame: Up to 21 days

  11. Excretion of 14C-labeled ASP3082 (radioactivity in urine): renal clearance (CLr)

    CLr will be recorded from urine samples collected.

    Time frame: Up to 21 days

  12. Excretion of 14C-labeled ASP3082 (radioactivity in feces): Ae

    Ae will be recorded from feces samples collected.

    Time frame: Up to 21 days

  13. Excretion of 14C-labeled ASP3082 (radioactivity in feces): Ae percentage

    Ae percentage will be recorded from feces samples collected.

    Time frame: Up to 21 days

  14. Excretion of 14C-labeled ASP3082 (radioactivity in feces): CumAe

    CumAe will be recorded from feces samples collected.

    Time frame: Up to 21 days

  15. Excretion of 14C-labeled ASP3082 (combined radioactivity in urine and feces): Ae

    Combined Ae will be recorded from urine and feces samples collected.

    Time frame: Up to 21 days

  16. 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.

    Time frame: Up to 21 days

  17. Excretion of 14C-labeled ASP3082 (combined radioactivity in urine and feces): CumAe

    Combined CumAe will be recorded from urine and feces samples collected.

    Time frame: Up to 21 days

Secondary outcomes

  1. 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

    Time frame: Up to 30 days

  2. Number of Participants with laboratory value abnormalities and/or AEs

    Number of participants with potentially clinically significant laboratory values.

    Time frame: Up to 30 days

  3. Number of Participants with vital sign abnormalities and/or AEs

    Number of participants with potentially clinically significant vital sign values.

    Time frame: Up to 30 days

  4. Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs

    Number of participants with potentially clinically significant ECG values.

    Time frame: Up to 30 days

  5. Metabolite identification of ASP3082 in plasma

    Identification of metabolites in plasma.

    Time frame: Up to 21 days

  6. Metabolite identification of ASP3082 in urine

    Identification of metabolites in urine.

    Time frame: Up to 21 days

  7. Metabolite identification of ASP3082 in feces

    Identification of metabolites in feces.

    Time frame: Up to 21 days

07

Study locations

1 site
  • Fortrea Clinical Research Unit Inc.
    Madison, Wisconsin 53704, United States
08

References and documents

Individual participant data

Plan to share: 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/.

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2026 to primary completion in Oct 2026, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2026
First posted
Aug 19, 2026
StartActual
Aug 28, 2026
Primary completionActual
Oct 20, 2026
CompletionActual
Oct 20, 2026
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting→Completed
changed Oct 7, 2026 · changed Nov 3, 2026
Sites
1 site added — first site in United States
Show site
  • Fortrea Clinical Research Unit Inc. · Madison, United States
Oct 7, 2026
Start date
Aug 31, 2026→Aug 28, 2026 (actual)
Oct 7, 2026
Primary completion
Oct 31, 2026→Oct 20, 2026 (actual)
Nov 3, 2026
Study completion
Oct 31, 2026→Oct 20, 2026 (actual)
Nov 3, 2026
Eligibility
1 exclusion criterion edited
What changed in the criteria
Exclusion criteria
  • EditedParticipant has any of the following conditions on day -1 or predose: mean pulse < 4540 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.
Oct 7, 2026
Show all 2 updates
  1. Nov 3, 2026
    Recruiting→Completed
    Primary completion Oct 31, 2026→Oct 20, 2026 (now actual)
    Study completion Oct 31, 2026→Oct 20, 2026 (now actual)
    + 3 other changes: verification date, contact details and site details
  2. Oct 7, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United States
    Show site
    • Fortrea Clinical Research Unit Inc. · Madison, United States
    Start date Aug 31, 2026→Aug 28, 2026 (now actual)
    Eligibility 1 exclusion criterion edited
    What changed in the criteria
    Exclusion criteria
    • EditedParticipant has any of the following conditions on day -1 or predose: mean pulse < 4540 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.
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07773129
Lead sponsor
Astellas Pharma Global Development, Inc.
Responsible party
Sponsor
First posted
Aug 19, 2026
Start date
Aug 28, 2026
Primary completion
Oct 20, 2026
Completion
Oct 20, 2026
Last update
Nov 3, 2026

Study contacts

Medical Director
study director · Astellas Pharma Global Development, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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