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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: varegacestat; Drug: Itraconazole (200 mg)

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85289
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Period 1: varegacestat administration for PK followed by Period 2: itraconazole and varegacestat administration for PK and DDI	Drug: varegacestat; Experimental intervention; Drug: Itraconazole (200 mg); Intervention to evaluate DDI with experimental intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of itraconazole on the PK of varegacestat in healthy participants.	AUC0-t for varegacestat administered with and without itraconazole.	Up to 5 weeks
Effect of itraconazole on the PK of varegacestat in healthy participants.	AUC0-inf for varegacestat administered with and without itraconazole.	Up to 5 weeks
Effect of itraconazole on the PK of varegacestat in healthy participants.	Cmax for varegacestat administered with and without itraconazole.	Up to 5 weeks
Effect of itraconazole on the PK of varegacestat in healthy participants.	Tmax for varegacestat administered with and without itraconazole.	Up to 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.	Number of subjects who experience treatment-emergent adverse events (TEAEs)	Up to 2 months
Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.	Number of subjects who experience abnormalities in clinical laboratory tests such as serum chemistry and hematology	Up to 2 months
Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.	Number of subjects who experience 12-lead ECG abnormalities	Up to 2 months
Ctrough of itraconazole and hydroxy-itraconazole in combination with varegacestat in healthy participants.	Ctrough. values on prior to dosing itraconazole	Up to 5 weeks

Collaborators and Investigators

• Sponsor: Immunome, Inc.
• Investigators: Principal Investigator: Michelle Valentine, Celerion

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): May 7, 2025

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Drug-Drug Interaction
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP3A Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: AL102-501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No