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

Detailed criteria

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

Drug
Varegacestat Reference Formulation
Oral administration
Drug
Varegacestat Test Formulation
Oral administration

Location

Celerion, Inc.
Tempe, Arizona

A Phase 1, Open-Label, Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Varegacestat Administered in Different Dose Forms in Healthy Participants

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions