A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorImmunome, Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Varegacestat Reference Formulation
- Varegacestat Test Formulation
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov