A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants

Phase 1

Active, not recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: varegacestat; Drug: Itraconazole (200 mg)

• Registration Number: NCT06677996
• Lead Sponsor: Immunome, Inc.

Brief Summary

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

Detailed Description

This is a phase 1, open-label, fixed sequence, 1-way crossover study examining the effect of itraconazole on the pharmacokinetics, safety and tolerability after varegacestat single dose administration to healthy participants. This is a 2-period study. In period 1 a single dose of varegacestat will be administered with PK evaluated predose and up to 192 hours postdose. There will be a 14 -day washout between period 1 and period 2. In period 2, itraconzole will be administered once daily for 18 consecutive days. Beginning on Day 4 of Period 2 a single dose of varegacestat will be administered 30 minutes after itraconazole dosing. Blood samples for PK will be collected prior to varegacestat dosing and up to 744 hours post varegacestat dosing for varegacestat and its metabolite.

Study Timeline

• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-07
• Study Start: 2024-11-11
• Status Verified: 2025-01
• Primary Completion: 2025-01
• Study Completion: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Healthy, adult, male or female (of non-childbearing potential only), 18 to 55 years of age, inclusive, 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 designee

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	varegacestat	Period 1: varegacestat administration for PK followed by Period 2: itraconazole and varegacestat administration for PK and DDI
Treatment Arm	Itraconazole (200 mg)	Period 1: varegacestat administration for PK followed by Period 2: itraconazole and varegacestat administration for PK and DDI

Primary Outcome Measures

Name	Time	Method
Effect of itraconazole on the PK of varegacestat in healthy participants.	Up to 5 weeks	Tmax for varegacestat administered with and without itraconazole.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.	Up to 2 months	Number of subjects who experience 12-lead ECG abnormalities
Ctrough of itraconazole and hydroxy-itraconazole in combination with varegacestat in healthy participants.	Up to 5 weeks	Ctrough. values on prior to dosing itraconazole

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States