A Phase 1 Mass Balance Study of Varegacestat (NCT06845852) | Clinical Trial Compass
CompletedPhase 1
A Phase 1 Mass Balance Study of Varegacestat
United States6 participantsStarted 2025-02-25
Plain-language summary
This clinical study is designed to study the mass balance of a single dose of varegacestat in healthy male participants.
Who can participate
Age range18 Years – 55 Years
SexMALE
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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.
What they're measuring
1
The mass balance of varegacestat following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.