A Phase 1 Mass Balance Study of Varegacestat

A Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]Varegacestat Following a Single Oral Dose in Healthy Adult Male Participants

This clinical study is designed to study the mass balance of a single dose of varegacestat in healthy male participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: varegacestat

Detailed Description

This is a single-center, open-label, Phase 1, mass balance study of varegacestat administered as a single oral dose (containing ~100 µCi) [14C]varegacestat in 6 healthy male participants.

Following completion of Screening and Day -1 assessments and an overnight fast of at least 10 hours, eligible participants will be administered a single dose (containing ~100 µCi) [14C]varegacestat as 2 oral capsules followed by approximately 240 mL room temperature filtered water on the morning of Day 1. Whole blood, plasma, urine, feces, and vomitus (if any, up to 24 hours post-dose) will be collected over at least 168 hours post-dose.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Secaucus, New Jersey, United States, 07094
      • Frontage Laboratories, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Be a male participant between 18 and 55 years of age, inclusive, at Screening.
• Medically healthy based on the absence of clinically significant abnormal vital sign measurements, clinical laboratory test results (especially tests for renal and hepatic function), resting 12-lead Electrocardiogram (ECG) evaluation, and physical examination, as determined by the Investigator at Screening and the Check-In visit.

Exclusion Criteria:

• 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.
• Have participated in a radiolabeled drug study or have been otherwise exposed to significant diagnostic (excluding dental X-rays), therapeutic, or occupational radiation, where exposure is made known to the Investigator, within one year prior to admission to the clinic for this study. The total estimated 12-month exposure to radio material or ionizing radiation should be below the CFR recommended levels considered safe (per US Title 21 CFR 361.1) or below 3000 mrem.
• Any condition which, in the opinion of the Investigator and/or Sponsor, would jeopardize participant safety or compliance with the Protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug: varegacestat; Single oral dose of varegacestat administered on study Day 1	Drug: varegacestat; Single oral dose of varegacestat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The mass balance of varegacestat following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.	Up to 15 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The total radioactivity in plasma, whole blood, urine, and feces following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.	Up to 15 days
The area under the concentration equivalent-time curve (AUC), from time 0 to the last observed non-zero concentration of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.	Up to 15 days
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 in plasma.	Up to 15 days
Maximum observed concentration (Cmax) of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.	Up to 15 days
Apparent first-order terminal elimination half-life (t1/2) will be calculated as 0.693/Kel of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.	Up to 15 days
Percentage of each metabolite in urine and feces relative to the administered dose or percentage of metabolites in plasma relative to total drug related exposure AUC.	Up to 15 days
The safety and tolerability of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants by incidences of treatment-emergent adverse events.	Up to 15 days

Collaborators and Investigators

• Sponsor: Immunome, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Actual): March 11, 2025
• Study Completion (Actual): March 26, 2025

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: metabolism; mass balance; absorption; excretion
• Other Study ID Numbers: AL102-504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No