A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants

A Phase 1, Open-Label, Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Varegacestat Administered in Different Dose Forms in Healthy Participants

This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting conditions.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Varegacestat Reference Formulation; Drug: Varegacestat Test Formulation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Immunome Medical Monitor; Phone Number: 425.939.7410; Email: info@immunome.com

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Recruiting
      • Celerion, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy, adult, female of non childbearing potential or male, 18 to 55 years of age, inclusive, at the screening visit
• Male participants must follow protocol-specified contraception guidance
• Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing
• BMI ≥ 18.0 and ≤ 32.0 kg/m2 and with a body weight > 50 kg at the screening visit
• Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee
• Able to swallow multiple capsules

Exclusion 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 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 poses an additional risk to the participant by their participation in the study
• History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
• History or presence of hypersensitivity or idiosyncratic reaction to varegacestat or related compounds

• History or presence of:

  • Autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus
  • Thrombophlebitis or deep vein thrombosis
  • Hematologic or coagulation disorders
  • Liver disease or dysfunction; Gilbert's syndrome
  • Renal dysfunction or glomerulonephritis
  • Cancer (except treated basal cell carcinoma of the skin and cancer-free for 5 years, non metastatic basal or squamous cell carcinoma of the skin, and cervical carcinoma in situ)
  • Clinically significant cardiovascular, gastrointestinal, pulmonary, endocrine, central nervous system disorders, or other major active and uncontrolled disease in the opinion of the PI or designee.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reference Formulation, then Test Formulation	Drug: Varegacestat Reference Formulation; Oral administration; Drug: Varegacestat Test Formulation; Oral administration
Experimental: Test Formulation, then Reference Formulation	Drug: Varegacestat Reference Formulation; Oral administration; Drug: Varegacestat Test Formulation; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the rBA of varegacestat by AUC0-t	Approximately 3 weeks
Evaluate the rBA of varegacestat by AUC0-inf	Approximately 3 weeks
Evaluate the rBA of varegacestat by Cmax	Approximately 3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess the safety and tolerability of varegacestat by incidence of treatment emergent adverse events	Approximately 4 weeks
Assess the safety and tolerability of varegacestat by incidence of laboratory abnormalities	Approximately 3 weeks
Assess the safety and tolerability of varegacestat by incidence of changes in vital signs from baseline	Approximately 3 weeks
Assess the safety and tolerability of varegacestat by incidence of changes from baseline of 12-lead ECG assessments	Approximately 3 weeks

Collaborators and Investigators

• Sponsor: Immunome, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: VAR-505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No