A Phase 1 interventional study of varegacestat and Placebo in Healthy Volunteer, sponsored by Immunome, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Immunome, Inc. · Phase 1, Interventional, and Other
This clinical study is designed to study the effect of a single dose of varegacestat on cardiac repolarization in healthy adult participants.
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.
Immunome, Inc. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: varegacestat
Drug: Placebo
Drug: Moxifloxacin 400 mg
Single oral dose of varegacestat
Single oral dose of placebo
Single oral dose of moxifloxacin
Placebo-corrected change from baseline QTc and varegacestat and its metabolite, AL102 MTB, plasma concentrations
Time frame: 24 hours
Change from baseline, placebo-corrected, and categorical outliers of the ECG parameter HR from a single oral dose of varegacestat.
Time frame: 24 hours
Change from baseline and placebo-corrected ECG parameter QT from a single oral dose of varegacestat.
Time frame: 24 hours
Change from baseline, placebo-corrected, and categorical outliers of the ECG parameter QTcF from a single oral dose of varegacestat.
Time frame: 24 hours
The AUC from time 0 extrapolated to infinity, calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant of varegacesatat and AL102-MTB (varegacestat metabolite).
Time frame: 7 days
Maximum observed concentration (Cmax) of varegacesatat and AL102-MTB (varegacestat metabolite).
Time frame: 7 days
Apparent first-order terminal elimination half-life (t1/2) will be calculated as 0.693/Kel of varegacesatat and AL102-MTB (varegacestat metabolite).
Time frame: 7 days
Safety and tolerability of a single oral dose of varegacestat by incidences of treatment-emergent adverse events.
Time frame: Approximately 56 days
Assay sensitivity of the study to detect a small QTc effect using moxifloxacin as a positive control.
Time frame: 24 hours
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Immunome, Inc.