Varegacestat: test if the new capsule works as well as the standard in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, randomized, crossover Phase 1 trial in healthy adults to compare the relative bioavailability and bioequivalence of the test varegacestat capsule formulations (A, B, C) against the reference capsule under fasting conditions. Participants will receive multiple dosing periods with washouts to measure blood levels and pharmacokinetic parameters. The study uses strict inclusion of healthy adults aged 18-55, with non-pregnant women and men, and excludes those with significant medical histories or other risk factors. Primary outcomes focus on pharmacokinetic comparisons to determine BE and rBA between formulations. The trial is sponsored by Immunome, Inc., with Celerion, Inc. conducting the clinical activities at their Tempe, Arizona site.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Immunome Medical Monitor
• Email: info@immunome.com
• Phone: 425.939.7410

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.