Recruiting
Phase 1

Varegacestat

Sponsor:

Immunome, Inc.

Code:

NCT07610005

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Varegacestat Reference Formulation

Varegacestat Test Formulation

Study Details

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

Study ID

NCT07610005

Start date

May 21, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Reference Formulation, then Test Formulation

experimental: Test Formulation, then Reference Formulation

Interventions

Varegacestat Reference Formulation

Oral administration

Varegacestat Test Formulation

Oral administration

Primary outcome measure

  • Evaluate the rBA of varegacestat by AUC0-t [ Time Frame: Approximately 3 weeks ]
  • Evaluate the rBA of varegacestat by AUC0-inf [ Time Frame: Approximately 3 weeks ]
  • Evaluate the rBA of varegacestat by Cmax [ Time Frame: Approximately 3 weeks ]

Central Contacts and Locations

Central contacts

Immunome Medical Monitor

425.939.7410info@immunome.com

Locations

Celerion, Inc.

Recruiting

Tempe, Arizona, United States, 85283

More Information

Sponsor

Immunome, Inc.

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Immunome, Inc. on 2026-06-08.