A Phase 1 Mass Balance Study of Varegacestat

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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

Key facts

Study ID: NCT06845852
Run by: Immunome, Inc.
People needed: 6
Starts: 2025-02-25
Expected to finish: 2025-03-26
Last updated by the study team: 2025-09-26

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

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.

Where it is running

Frontage Laboratories, Inc. — Secaucus, New Jersey, United States

Full record on ClinicalTrials.gov

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