NCT06845852

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Immunome, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	varegacestat	Single oral dose of varegacestat

Timeline

• Start date: 2025-02-25
• Primary completion: 2025-03-11
• Completion: 2025-03-26
• First posted: 2025-02-25
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study