NCT06855264

A Cardiac Liability Study of Varegacestat in Healthy Participants

A Phase 1, Randomized, Single-Dose, Positive- and Placebo-Controlled, 3-Way Crossover Study to Evaluate the Effects of Varegacestat on Cardiac Repolarization in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Immunome, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a double-blind (with respect to varegacestat and placebo only), single-dose, randomized, placebo- and positive- controlled, 3-way crossover study. On Day 1 of each period, participants will receive one of 3 treatments: a single dose of varegacestat (Treatment A), a single dose of varegacestat matching placebo (Treatment B), or a single dose of moxifloxacin (Treatment C). In each period, cardiodynamic ECGs will be collected predose and for 24 hours postdose. PK samples will be collected predose and up to 168 hours post-dose for assessments of varegacestat and AL102 MTB, and up to 24 hours post-dose for assessment of moxifloxacin. There will be a washout of at least 14 days between doses. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	varegacestat	Single oral dose of varegacestat
DRUG	Placebo	Single oral dose of placebo
DRUG	Moxifloxacin 400 mg	Single oral dose of moxifloxacin

Timeline

• Start date: 2025-02-24
• Primary completion: 2025-04-08
• Completion: 2025-05-06
• First posted: 2025-03-03
• Last updated: 2025-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study