A Cardiac Liability Study of Varegacestat in Healthy Participants

NCT06855264 | Completed Phase 1 FDA Drug

• 1 other identifier: AL102-502
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

thorough-QT

Outcome Measures

Primary Outcomes (1)

• Placebo-corrected change from baseline QTc and varegacestat and its metabolite, AL102 MTB, plasma concentrations

  24 hours

Secondary Outcomes (8)

• Change from baseline, placebo-corrected, and categorical outliers of the ECG parameter HR from a single oral dose of varegacestat.

  24 hours

• Change from baseline and placebo-corrected ECG parameter QT from a single oral dose of varegacestat.

  24 hours

• Change from baseline, placebo-corrected, and categorical outliers of the ECG parameter QTcF from a single oral dose of varegacestat.

  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).

  7 days

• Maximum observed concentration (Cmax) of varegacesatat and AL102-MTB (varegacestat metabolite).

  7 days

Study Arms (3)

Varegacestat

EXPERIMENTAL

Drug: varegacestat

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin 400 mg

Interventions

varegacestat DRUG

Single oral dose of varegacestat

Varegacestat

Placebo DRUG

Single oral dose of placebo

Placebo

Moxifloxacin 400 mg DRUG

Single oral dose of moxifloxacin

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, male or female (of non childbearing potential), 18 to 55 years of age, inclusive, at the screening visit.
• Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, and vital signs, as deemed by the PI or designee

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunome, Inc.: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85289, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator) This is a double-blind study (with respect to varegacestat and placebo only; moxifloxacin will be open label).
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: February 24, 2025
• Primary Completion: April 8, 2025
• Study Completion: May 6, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (1)