A Phase 1 Mass Balance Study of Varegacestat

NCT06845852 | Completed Phase 1 FDA Drug

• 1 other identifier: AL102-504
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

absorption; metabolism; excretion; mass balance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

Drug: varegacestat

EXPERIMENTAL

Single oral dose of varegacestat administered on study Day 1

Drug: varegacestat

Interventions

varegacestat DRUG

Single oral dose of varegacestat

Drug: varegacestat

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunome, Inc.: lead

Study Sites (1)

Frontage Laboratories, Inc.

Secaucus, New Jersey, 07094, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 25, 2025
• Study Start: February 25, 2025
• Primary Completion: March 11, 2025
• Study Completion: March 26, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)