Varegacestat for Healthy Volunteers

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Immunome, Inc.

Disqualifiers: Recent investigational drug, radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the body processes a single dose of varegacestat, a new drug under study in healthy male volunteers. Researchers are examining how the drug moves through the body and how it breaks down. Healthy males who have not participated in another drug trial recently and have no major health issues are suitable candidates for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that varegacestat is likely to be safe for humans?

Previous studies have tested varegacestat in healthy volunteers to assess its safety. One study examined the drug's interaction with itraconazole, a common antifungal medication, and identified some side effects after administration. Such findings are typical in early research and help determine the drug's tolerability.

Another study investigated the effects of varegacestat on individuals with liver problems and healthy participants. Although specific results are not provided, monitoring liver effects is a standard part of early testing to ensure safety.

Varegacestat belongs to a group of drugs called GSIs (gamma-secretase inhibitors), which have an established safety profile. Researchers have some knowledge of the usual side effects and how to manage them.

As this trial is in the first phase, it represents the initial step in testing the drug in humans, focusing primarily on identifying any side effects. This stage typically involves fewer participants, with an emphasis on safety rather than effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Varegacestat is unique because it targets the gamma-secretase enzyme, a mechanism not typically exploited by current treatments. Most existing therapies focus on different pathways or symptoms, but varegacestat's novel approach has the potential to address underlying causes more directly. Researchers are excited about this treatment because it represents a new way to tackle the condition, potentially offering more effective results or fewer side effects compared to traditional options.

What evidence suggests that varegacestat could be effective?

Research has shown that varegacestat, an oral medication, has potential in treating certain conditions. In a study on desmoid tumors, varegacestat reduced tumor size in 71.4% of patients, indicating its ability to manage tumors by affecting specific cell processes. Although this trial focuses on healthy volunteers, the mechanism of varegacestat suggests it might benefit other conditions as well. Further studies will clarify its effectiveness in various medical situations. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Varegacestat

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06841315

NCT06841315 | A Varegacestat Hepatic Impairment Study

A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06677996

NCT06677996 | A Phase 1 Study to Examine the Effects of ...

This is a phase 1, open-label, fixed sequence, 1-way crossover study examining the effect of itraconazole on the pharmacokinetics, safety and tolerability

3.

clinicaltrials.eu

clinicaltrials.eu/inn/varegacestat/

Varegacestat – Application in Therapy and Current Clinical ...

This trial is designed for healthy volunteers. It does not involve individuals with specific medical conditions. What are the main outcomes being measured in ...

4.

sigma.larvol.com

sigma.larvol.com/product.php?e1=853800&tab=newstrac

varegacestat (AL102) News

An oral GSI (PF-03084014) was effective in treating desmoid tumors with an objective response rate (ORR) of 71.4% in a Phase 1 study with 7 patients (Villalobos ...

5.

synapse.patsnap.com

synapse.patsnap.com/drug/a1c2961b81954e26949d39a2db9d6e54

Varegacestat - Drug Targets, Indications, Patents

... Study to Evaluate the Effects of Varegacestat on Cardiac Repolarization in Healthy Participants. 100 Clinical Results associated with Varegacestat. Login to ...

6.

withpower.com

withpower.com/trial/phase-1-liver-diseases-1-2025-a8f6e

Varegacestat for Liver Disease

Is Varegacestat safe for human use? There is no specific safety data available for Varegacestat in the provided research articles. Are You a Good ...