Who is eligible for clinical trial NCT07610005?

Participants must meet protocol criteria for Healthy. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07610005 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-04

A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants (NCT07610005)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Immunome, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (14 items).

Location: Celerion, Inc. — Tempe, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Celerion, Inc. — Tempe, Arizona

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗