RecruitingPhase 1NCT07610005

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

Sponsor

Immunome, Inc.

Enrollment

20 participants

Start Date

May 21, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria6

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 Criteria13

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.