NCT06677996

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Immunome, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	varegacestat	Experimental intervention
DRUG	Itraconazole (200 mg)	Intervention to evaluate DDI with experimental intervention

Timeline

• Start date: 2024-11-11
• Primary completion: 2024-12-30
• Completion: 2025-05-07
• First posted: 2024-11-07
• Last updated: 2025-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study