Varegacestat for Healthy Volunteers

Age: 18 - 65

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Immunome, Inc.

Disqualifiers: Recent investigational drug, radiation, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This clinical study is designed to study the mass balance of a single dose of varegacestat in healthy male participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Eligibility Criteria

This trial is for healthy male participants who meet specific health criteria. The exact inclusion and exclusion details are not provided, but typically these would involve certain age ranges, no current medications or health conditions that could interfere with the study.

Inclusion Criteria

I am a man aged between 18 and 55.

I am generally healthy with no significant health issues as confirmed by recent medical tests.

Exclusion Criteria

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 Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of [14C]varegacestat following an overnight fast

1 day

1 visit (in-person)

Follow-up

Participants are monitored for absorption, metabolism, excretion, and mass balance of varegacestat

168 hours

Treatment Details

Interventions

• Varegacestat (Gamma Secretase Inhibitor)

Trial Overview The study is focused on understanding how a single dose of varegacestat is processed in the body. This includes tracking how much of the drug is absorbed, distributed, metabolized, and eventually excreted after administration.

Participant Groups

Group I: Drug: varegacestat Experimental Treatment 1 Intervention

Single oral dose of varegacestat administered on study Day 1

Who Is Running the Clinical Trial?

Immunome, Inc.

Lead Sponsor

Trials

7

Recruited

420+