Varegacestat for Healthy Subjects

Overseen By Michelle Valentine

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Immunome, Inc.

Disqualifiers: Recent investigational drug, others

Compensation: Varies

Number of Visits: 3

Duration: 1 day per period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests varegacestat, a new treatment, to assess its effects on heart rhythms in healthy adults. Researchers aim to compare its impact with a placebo (a harmless pill with no effect) and a known drug, moxifloxacin. Participants who are generally healthy and have no major medical history may be suitable for this study. As a Phase 1 trial, this research focuses on understanding how varegacestat works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken an investigational drug recently, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that varegacestat is generally well tolerated. In earlier studies, researchers tested varegacestat on healthy volunteers and patients with various conditions. These studies found that the drug had a manageable safety profile, with most people not experiencing severe side effects.

For example, one study found that while some participants experienced new side effects, these were usually mild and not serious. Varegacestat is currently being tested in a Phase 1 trial, which is often the first step in testing a new treatment in humans. This phase mainly focuses on safety and how well people handle the drug.

Overall, the data so far suggests that varegacestat is well tolerated in the tested groups. However, as with any new treatment, some risks may still exist. Participants should consider these findings and discuss them with healthcare providers when deciding to join a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Varegacestat is unique because it represents a new approach in treating conditions associated with amyloid plaques, like Alzheimer's disease. Most current treatments focus on alleviating symptoms, but Varegacestat works differently, targeting the production of amyloid-beta peptides by inhibiting gamma-secretase, an enzyme involved in their creation. This could potentially slow down the disease progression rather than just managing symptoms. Researchers are excited about Varegacestat because its innovative mechanism of action could change the way we approach diseases linked to amyloid accumulation, offering hope for more effective long-term management.

What evidence suggests that this trial's treatments could be effective?

Research has shown that varegacestat, a gamma secretase inhibitor, has potential benefits in clinical studies. In a previous study, 75% of evaluable patients responded positively to the drug, and 64% of all participants showed a positive response. This suggests the drug might work well for many patients. In this trial, some participants will receive varegacestat, while others will receive either moxifloxacin or a placebo. Early trials focus on understanding how the drug works and ensuring its safety for healthy volunteers. These results offer hope for further development of varegacestat. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for healthy adults, both male and female (females must be of non-childbearing potential), aged 18 to 55. Participants should have no significant medical history or conditions that could affect the study results or increase risk.

Inclusion Criteria

I am generally healthy with no significant medical issues.

I am a healthy adult between 18 and 55 years old and cannot have children.

Exclusion Criteria

History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of varegacestat, placebo, or moxifloxacin in a 3-way crossover design. Cardiodynamic ECGs and PK samples are collected.

1 day per period

3 visits (in-person, one per period)

Washout

A washout period of at least 14 days between each treatment dose to clear the previous treatment from the body.

14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Varegacestat

Trial Overview The study tests the effect of a single dose of Varegacestat on heart function compared to a placebo and Moxifloxacin (an antibiotic known to have cardiac effects). It's designed to ensure Varegacestat doesn't adversely affect the heart's electrical cycle.

How Is the Trial Designed?

Group I: Varegacestat Experimental Treatment 1 Intervention

Group II: Moxifloxacin Active Control 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

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 They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.11516

Subgroup analysis of the phase 2 part of the RINGSIDE ... The RINGSIDE Phase 2 study (NCT04871282) demonstrated early and continued response to three dose regimens of varegacestat (AL102) in patients ...

3. immunome.com immunome.com/pipeline/al102-gamma-secretase-inhibitor/

Varegacestat (Gamma Secretase Inhibitor) In the Phase 2 RINGSIDE study (Part A), varegacestat demonstrated objective response rates (ORR) of 75% of evaluable patients and 64% in the intent-to-treat ...

4. clinicaltrials.eu clinicaltrials.eu/inn/varegacestat/

Varegacestat – Application in Therapy and Current Clinical ... This article discusses a Phase 1 clinical trial examining the effects of itraconazole on the pharmacokinetics, safety, and tolerability of Varegacestat (AL102) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06677996

NCT06677996 | A Phase 1 Study to Examine the Effects of ... A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants. ClinicalTrials.gov ID ...