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Varegacestat Reference Formulation

Phase 1

Healthy | Small molecule | Other |Immunome, Inc.|Last Updated: Jun 8, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Varegacestat Reference Formulation · 1 trial · 1 indication

Phase 1 1
NCT07610005A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy ParticipantsHealthy
RECRUITING20 Analytics
PHASE1RECRUITING
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the rBA of varegacestat by AUC0-t
Approximately 3 weeks
Evaluate the rBA of varegacestat by AUC0-inf
Approximately 3 weeks
Evaluate the rBA of varegacestat by Cmax
Approximately 3 weeks

Secondary Endpoints

Assess the safety and tolerability of varegacestat by incidence of treatment emergent adverse events
Approximately 4 weeks
Assess the safety and tolerability of varegacestat by incidence of laboratory abnormalities
Approximately 3 weeks
Assess the safety and tolerability of varegacestat by incidence of changes in vital signs from baseline
Approximately 3 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Reference Formulation, then Test FormulationEXPERIMENTAL -
Test Formulation, then Reference FormulationEXPERIMENTAL -

Interventions

NameTypeDescription
Varegacestat Reference FormulationDRUGOral administration
Varegacestat Test FormulationDRUGOral administration
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 fo...

Countries:United States
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Recent Changes (Last 90 Days)

LOWJun 8, 2026NCT07610005startDate: changed
LOWJun 8, 2026NCT07610005startDate: changed
LOWJun 8, 2026NCT07610005startDate: changed

Frequently asked questions about Varegacestat Reference Formulation

What is Varegacestat Reference Formulation used for?

Varegacestat Reference Formulation is an investigational small molecule being studied in healthy volunteers. It is being evaluated in Phase 1 clinical trials to examine its effects, including how it interacts with other drugs, how the body processes it, and its bioavailability. It is not approved for any disease and remains in clinical development.

Who makes Varegacestat Reference Formulation?

Varegacestat Reference Formulation is being developed by Immunome, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IMNM. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy participants in the United States.

What phase is Varegacestat Reference Formulation in?

Varegacestat Reference Formulation is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Four Phase 1 trials have been conducted or initiated, with one currently recruiting participants and the others completed.

What clinical trials is Varegacestat Reference Formulation in?

Varegacestat Reference Formulation has been studied in four Phase 1 trials. These include NCT06677996, examining effects of itraconazole after single dose administration; NCT06841315, a hepatic impairment study; NCT06845852, a mass balance study; and NCT07610005, a relative bioavailability and bioequivalence study, which is currently recruiting.

What does Varegacestat Reference Formulation target?

Varegacestat Reference Formulation belongs to the -stat class of enzyme inhibitors, indicating it targets an enzyme. The specific molecular target is not disclosed in the available clinical trial information. It is being studied in healthy volunteers to assess its pharmacokinetic properties and safety.

Is Varegacestat Reference Formulation the same as AL102?

Yes, Varegacestat is also known as AL102. In clinical trial NCT06677996, the study title refers to Varegacestat (AL102), confirming these names refer to the same investigational drug. This alternative name may appear in scientific literature and other trial registrations.