NCT06841315

A Varegacestat Hepatic Impairment Study

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Varegacestat in Participants With or Without Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Immunome, Inc. · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is designed to determine the pharmacokinetics, safety and tolerability of varegacestat in people with impaired liver function compared to people with normal liver function.

Detailed description

This is an open-label, single-dose, parallel study to evaluate the effects of varying degrees of impaired hepatic function on the PK, safety, and tolerability of varegacestat in adult participants. The study will be conducted sequentially. The study will enroll participants with mild (Group 2) and moderate (Group 3) hepatic impairment (HI) and healthy participants with normal hepatic function (Group 1) at a 1:1 ratio. Matched healthy participants may match to more than one participant in the HI groups. Subsequently, if appropriate, the study will enroll participants with severe (Group 4) HI and healthy participants with normal hepatic function (Group 1), as needed, to provide 1:1 matches for Group 4. The decision to conduct Group 4 enrollment will be contingent upon the assessment of the feasibility, PK, and safety data from Groups 1-3.

Conditions

• Healthy Volunteer
• Hepatic Impairment (HI)

Interventions

Type	Name	Description
DRUG	varegacestat	experimental intervention

Timeline

• Start date: 2025-03-07
• Primary completion: 2025-11-05
• Completion: 2026-03-06
• First posted: 2025-02-24
• Last updated: 2026-03-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study