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Varegacestat Bioavailability Study in Healthy Participants

This study is looking for healthy adults aged 18 to 55 to compare two different capsule forms of varegacestat. Researchers want to see how well the body absorbs and uses a "test" capsule of varegacestat compared to a "reference" capsule. This is important for understanding if the different forms deliver the drug similarly. The study will measure the amount of varegacestat in your body over approximately three weeks. We are looking to enroll about 20 participants for this study. The current recruitment status is unclear.

Study design
This is an open-label, randomized, crossover study, meaning you and the researchers will know which form of varegacestat you are taking, and you will receive both forms at different times. Approximately 20 healthy participants will be enrolled.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate the drug levels over approximately 3 weeks.

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NCT07610005

A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants

Recruiting
PHASE1Ages 18–55Interventional
Immunome, Inc.
~20 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Varegacestat Reference FormulationVaregacestat Test Formulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the rBA of varegacestat by AUC0-t
Measured over Approximately 3 weeks
+2 more outcomes measured

Conditions

Healthy

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Arizona1

Who to contact

Immunome Medical Monitor
[email protected]
425.939.7410
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Evaluate the rBA of varegacestat by AUC0-tApproximately 3 weeks
  • Evaluate the rBA of varegacestat by AUC0-infApproximately 3 weeks
  • Evaluate the rBA of varegacestat by CmaxApproximately 3 weeks