A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Immunome, Inc.
Study ID
NCT07610005
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Varegacestat Reference Formulation — DRUG
    Oral administration
  • Varegacestat Test Formulation — DRUG
    Oral administration

Study Details

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.

Key Dates

Start date
May 21, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Reference Formulation, then Test Formulation
  • Experimental: Test Formulation, then Reference Formulation

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, Inc.TempeArizona85283-

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Celerion, Inc.· Tempe, AZ

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