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

32 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

This clinical study is designed to study the effect of a single dose of varegacestat on cardiac repolarization in healthy adult participants.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+