Healthy VolunteerPhase 1NCT06845852
A Phase 1 Mass Balance Study of Varegacestat
A Phase 1 study testing varegacestat in people with Healthy Volunteer, run by Immunome, Inc. at 1 site in United States.
Trial summary
This clinical study is designed to study the mass balance of a single dose of varegacestat in healthy male participants. 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 Volunteer
- What is being tested?
- varegacestat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 26 Mar 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
- Be a male participant between 18 and 55 years of age, inclusive, at Screening.
- Medically healthy based on the absence of clinically significant abnormal vital sign measurements, clinical laboratory test results (especially tests for renal and hepatic function), resting 12-lead Electrocardiogram (ECG) evaluation, and physical examination, as determined by the Investigator at Screening and the Check-In visit.
Who cannot join
- Have taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer.
- Have participated in a radiolabeled drug study or have been otherwise exposed to significant diagnostic (excluding dental X-rays), therapeutic, or occupational radiation, where exposure is made known to the Investigator, within one year prior to admission to the clinic for this study. The total estimated 12-month exposure to radio material or ionizing radiation should be below the CFR recommended levels considered safe (per US Title 21 CFR 361.1) or below 3000 mrem.
- Any condition which, in the opinion of the Investigator and/or Sponsor, would jeopardize participant safety or compliance with the Protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Laboratories, Inc.
Secaucus, New Jersey, 07094
About this study
Official title: A Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]Varegacestat Following a Single Oral Dose in Healthy Adult Male Participants
This clinical study is designed to study the mass balance of a single dose of varegacestat in healthy male participants.
Read the detailed description
This is a single-center, open-label, Phase 1, mass balance study of varegacestat administered as a single oral dose (containing ~100 µCi) [14C]varegacestat in 6 healthy male participants.
Following completion of Screening and Day -1 assessments and an overnight fast of at least 10 hours, eligible participants will be administered a single dose (containing ~100 µCi) [14C]varegacestat as 2 oral capsules followed by approximately 240 mL room temperature filtered water on the morning of Day 1. Whole blood, plasma, urine, feces, and vomitus (if any, up to 24 hours post-dose) will be collected over at least 168 hours post-dose.
- Conditions
- Healthy Volunteer
- Being tested
- varegacestat
- Keywords
- absorption, metabolism, excretion, mass balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varegacestatDrug
Single oral dose of varegacestat
| Study group | Role | What they receive |
|---|---|---|
| Drug: varegacestat | Experimental | Single oral dose of varegacestat administered on study Day 1 Receives: Drug: varegacestat |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mass balance of varegacestat following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.
Measured: Up to 15 days
Secondary outcomes (7)
The total radioactivity in plasma, whole blood, urine, and feces following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.
Measured: Up to 15 days
The area under the concentration equivalent-time curve (AUC), from time 0 to the last observed non-zero concentration of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.
Measured: Up to 15 days
The AUC from time 0 extrapolated to infinity, calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant of varegacesatat and AL102-MTB in plasma.
Measured: Up to 15 days
Maximum observed concentration (Cmax) of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.
Measured: Up to 15 days
Apparent first-order terminal elimination half-life (t1/2) will be calculated as 0.693/Kel of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.
Measured: Up to 15 days
Percentage of each metabolite in urine and feces relative to the administered dose or percentage of metabolites in plasma relative to total drug related exposure AUC.
Measured: Up to 15 days
The safety and tolerability of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants by incidences of treatment-emergent adverse events.
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start25 Feb 2025
- Primary completion11 Mar 2025
- Study completion26 Mar 2025
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunome, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845852
- Sponsor's protocol ID
- AL102-504
- Status last verified
- Sep 2025
- First submitted
- 5 Feb 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]Varegacestat Following a Single Oral Dose in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT06845852
- Acronym / sponsor ID
- AL102-504
- Conditions
- Healthy Volunteer
- Keywords
- absorption, metabolism, excretion, mass balance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Immunome, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 25 Feb 2025 (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.
This clinical study is designed to study the mass balance of a single dose of varegacestat in healthy male participants.
Detailed description
This is a single-center, open-label, Phase 1, mass balance study of varegacestat administered as a single oral dose (containing ~100 µCi) [14C]varegacestat in 6 healthy male participants.
Following completion of Screening and Day -1 assessments and an overnight fast of at least 10 hours, eligible participants will be administered a single dose (containing ~100 µCi) [14C]varegacestat as 2 oral capsules followed by approximately 240 mL room temperature filtered water on the morning of Day 1. Whole blood, plasma, urine, feces, and vomitus (if any, up to 24 hours post-dose) will be collected over at least 168 hours post-dose.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug: varegacestat | Experimental | Drug: varegacestatSingle oral dose of varegacestat administered on study Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Be a male participant between 18 and 55 years of age, inclusive, at Screening.
- Medically healthy based on the absence of clinically significant abnormal vital sign measurements, clinical laboratory test results (especially tests for renal and hepatic function), resting 12-lead Electrocardiogram (ECG) evaluation, and physical examination, as determined by the Investigator at Screening and the Check-In visit.
Key exclusion criteria (3 listed)
- Have taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer.
- Have participated in a radiolabeled drug study or have been otherwise exposed to significant diagnostic (excluding dental X-rays), therapeutic, or occupational radiation, where exposure is made known to the Investigator, within one year prior to admission to the clinic for this study. The total estimated 12-month exposure to radio material or ionizing radiation should be below the CFR recommended levels considered safe (per US Title 21 CFR 361.1) or below 3000 mrem.
- Any condition which, in the opinion of the Investigator and/or Sponsor, would jeopardize participant safety or compliance with the Protocol.
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 |
|---|---|---|
| varegacestatSingle oral dose of varegacestat | Drug | Drug: varegacestat |
Primary outcome
The mass balance of varegacestat following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.
Time frame: Up to 15 days
7 secondary outcomes
The total radioactivity in plasma, whole blood, urine, and feces following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.
Time frame: Up to 15 days
The area under the concentration equivalent-time curve (AUC), from time 0 to the last observed non-zero concentration of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.
Time frame: Up to 15 days
The AUC from time 0 extrapolated to infinity, calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant of varegacesatat and AL102-MTB in plasma.
Time frame: Up to 15 days
Maximum observed concentration (Cmax) of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.
Time frame: Up to 15 days
Apparent first-order terminal elimination half-life (t1/2) will be calculated as 0.693/Kel of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.
Time frame: Up to 15 days
Percentage of each metabolite in urine and feces relative to the administered dose or percentage of metabolites in plasma relative to total drug related exposure AUC.
Time frame: Up to 15 days
The safety and tolerability of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants by incidences of treatment-emergent adverse events.
Time frame: Up to 15 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 26 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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 varegacestat in people with Healthy Volunteer, run by Immunome, 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 2 inclusion and 3 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 26 Sep 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?
The mass balance of varegacestat following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants. (time frame: Up to 15 days). 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 26 Sep 2025.