A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants

NCT07610005 | Recruiting Phase 1 FDA Drug

• 1 other identifier: VAR-505
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

Reference Formulation, then Test Formulation

EXPERIMENTAL

Drug: Varegacestat Reference Formulation; Drug: Varegacestat Test Formulation

Test Formulation, then Reference Formulation

EXPERIMENTAL

Drug: Varegacestat Reference Formulation; Drug: Varegacestat Test Formulation

Interventions

Varegacestat Reference Formulation DRUG

Oral administration

Reference Formulation, then Test Formulation; Test Formulation, then Reference Formulation

Varegacestat Test Formulation DRUG

Oral administration

Reference Formulation, then Test Formulation; Test Formulation, then Reference Formulation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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.

Sponsors & Collaborators

• Immunome, Inc.: lead

Study Sites (1)

Celerion, Inc.

Tempe, Arizona, 85283, United States

RECRUITING

Central Study Contacts

Immunome Medical Monitor

CONTACT

425.939.7410; info@immunome.com

Study Design

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

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: May 21, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (1)