A Varegacestat Hepatic Impairment Study

NCT06841315 | Completed Phase 1 FDA Drug

• 1 other identifier: AL102-503
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Volunteer; Hepatic Impairment (HI)

Outcome Measures

Primary Outcomes (3)

• PK of varegacestat and metabolite from a single oral dose of varegacestat in hepatic impaired adult participants to matched healthy adult participants.

  AUC0-t varegacestat and metabolite

  Up to 4 weeks

• PK of varegacestat and metabolite from a single oral dose of varegacestat in hepatic impaired adult participants to matched healthy adult participants.

  AUC0-inf for varegacestat and metabolite

  Up to 4 weeks

• PK of varegacestat and metabolite from a single oral dose of varegacestat in hepatic impaired adult participants to matched healthy adult participants.

  Cmax for varegacestat and metabolite

  Up to 4 weeks

Secondary Outcomes (3)

• Assess the safety and tolerability of a single oral dose of varegacestat in hepatic impaired adult participants and in matched healthy adult participants.

  Up to 4 weeks

• Assess the safety and tolerability of a single oral dose of varegacestat in hepatic impaired adult participants and in matched healthy adult participants.

  Up to 4 weeks

• Assess the safety and tolerability of a single oral dose of varegacestat in hepatic impaired adult participants and in matched healthy adult participants.

  Up to 4 weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Single oral dose of varegacestat administered on study day 1

Drug: varegacestat

Interventions

varegacestat DRUG

experimental intervention

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, adult, male or female (of nonchildbearing potential only), 18 to 84 years of age, inclusive, at the screening visit. Participant will be matched by age (± 10 years) and sex to a participant with hepatic impairment (HI). Each healthy participant may be matched to more than 1 participant with HI, but cannot be matched to more than 1 participant within the same HI group.
• Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs as deemed by the PI or designee
• Healthy, apart from HI, adult male or female (of nonchildbearing potential only), 18 to 84 years of age, inclusive, at the screening visit.
• Considered to have HI (of any etiology) that has been clinically stable (no acute episodes of illness due to deterioration in hepatic function) for at least 1 month prior to dosing per the PI and Sponsor and is likely to remain stable throughout the study. To be classified as having hepatic impairment with known medical history of liver disease (with or without a known history of alcohol abuse).
• Has a score on the Child-Pugh scale at screening visit and confirmed at check-in as follows:
• Mild: ≥5 and ≤6 \[Category A\]; or
• Moderate: ≥7 and ≤9 \[Category B\]; or
• Severe: ≥10 and ≤15 \[Category C\].
• \- Medically healthy, apart from HI, with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs as deemed by the PI or designee

You may not qualify if:

• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
• History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
• Participants must not be enrolled in the study, if they meet any of the following criteria:
• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical (except for HI) or psychiatric condition or disease in the opinion of the PI or designee.
• History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study.

Sponsors & Collaborators

• Immunome, Inc.: lead

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy participants (Group 1) will be matched by age (± 10 years), body mass index (BMI, ± 15%), and sex to participants with mild to moderate hepatic impairment (Groups 2 and 3). Participants with severe hepatic impairment (Group 4) will be included as needed and matched to Group 1.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 24, 2025
• Study Start: March 7, 2025
• Primary Completion: November 5, 2025
• Study Completion: March 6, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (2)