Varegacestat + Itraconazole Interaction Study in Healthy Subjects

Overseen By Michelle Valentine

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Immunome, Inc.

Disqualifiers: Significant emotional problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open label, fixed sequence, 1-way crossover drug-drug interaction (DDI) study in healthy participants.

Research Team

Michelle Valentine

Principal Investigator

Celerion

Eligibility Criteria

This trial is for healthy individuals who can participate in a study to understand how the drug Varegacestat interacts with Itraconazole. Specific eligibility criteria are not provided, but typically participants must be adults without any significant health issues.

Inclusion Criteria

Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee

I am a healthy adult between 18 and 55 years old and cannot have children.

Exclusion Criteria

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

I have a significant health or mental condition as assessed by my doctor.

I am mentally capable and do not have significant emotional issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Single dose of varegacestat administered with PK evaluated predose and up to 192 hours postdose

1 week

Washout

14-day washout period between Period 1 and Period 2

2 weeks

Treatment Period 2

Itraconazole administered once daily for 18 days; varegacestat administered on Day 4 with PK evaluation up to 744 hours postdose

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Itraconazole
• Varegacestat

Trial Overview The study is testing the effects of Itraconazole on the body's response to a single dose of Varegacestat. It's an open-label and crossover study, meaning everyone knows what treatment they're getting and participants will receive both drugs at different times.

Participant Groups

Group I: Treatment Arm Experimental Treatment 2 Interventions

Period 1: varegacestat administration for PK followed by Period 2: itraconazole and varegacestat administration for PK and DDI

Who Is Running the Clinical Trial?

Immunome, Inc.

Lead Sponsor

Trials

7

Recruited

420+