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44 Participants NeededMy employer runs this trial

Varegacestat Formulations for Healthy Subjects

IM
Overseen ByImmunome Medical Monitor
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Immunome, Inc.
Disqualifiers: Autoimmune disease, Liver disease, Cancer, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for healthy men and women (not able to have children), ages 18-55, who don't smoke or use nicotine, have a BMI between 18 and 32, weigh over 50 kg, are in good health with no major medical issues, and can swallow multiple capsules.

Inclusion Criteria

I have not used any nicotine or tobacco products for at least 3 months.
My BMI is between 18 and 32, and I weigh more than 50 kg.
I am medically healthy with no significant health issues.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive different formulations of varegacestat in a crossover design to assess bioavailability and bioequivalence

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares how different capsule forms of the drug varegacestat are absorbed by the body. Participants will receive several versions of the medication in random order while fasting to see if they work similarly.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Part 2: Test Formulation C, then Reference FormulationExperimental Treatment2 Interventions
Group II: Part 2: Test Formulation B, then Reference FormulationExperimental Treatment2 Interventions
Group III: Part 2: Reference Formulation, then Test Formulation CExperimental Treatment2 Interventions
Group IV: Part 2: Reference Formulation, then Test Formulation BExperimental Treatment2 Interventions
Group V: Part 1: Test Formulation A, then Reference FormulationExperimental Treatment2 Interventions
Group VI: Part 1: Reference Formulation, then Test Formulation AExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Immunome, Inc.

Lead Sponsor

Trials
7
Recruited
420+

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