Clinical trial NCT06845852: A Phase 1 Mass Balance Study of Varegacestat
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: absorption
metabolism
excretion
mass balance
Lead sponsor: Immunome, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-25
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The mass balance of varegacestat following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.
timeFrame: Up to 15 days
Secondary outcomes:
measure: 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.
timeFrame: Up to 15 days
measure: 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.
timeFrame: Up to 15 days
measure: 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.
timeFrame: Up to 15 days
measure: Maximum observed concentration (Cmax) of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.
timeFrame: Up to 15 days
measure: 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.
timeFrame: Up to 15 days
measure: 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.
timeFrame: Up to 15 days
measure: 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.
timeFrame: Up to 15 days
Other outcomes:
Locations:
city: Secaucus
country: United States
facility: Frontage Laboratories, Inc.
state: New Jersey
Study officials:
References: