A Phase 1, Open-Label, Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Varegacestat Administered in Different Dose Forms in Healthy Participants
Immunome, Inc.
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
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 des…
Interventions
- DrugVaregacestat Reference Formulation
Oral administration
- DrugVaregacestat Test Formulation
Oral administration
Location
- Celerion, Inc.Tempe, Arizona