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

NCT06677996 | Completed Phase 1 FDA Drug

• 1 other identifier: AL102-501
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Drug-Drug Interaction; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.

  Up to 2 months

• Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.

  Up to 2 months

• Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.

  Up to 2 months

• Ctrough of itraconazole and hydroxy-itraconazole in combination with varegacestat in healthy participants.

  Up to 5 weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Drug: varegacestat; Drug: Itraconazole (200 mg)

Interventions

varegacestat DRUG

Experimental intervention

Treatment Arm

Itraconazole (200 mg) DRUG

Intervention to evaluate DDI with experimental intervention

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunome, Inc.: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85289, United States

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Michelle Valentine

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 7, 2024
• Study Start: November 11, 2024
• Primary Completion: December 30, 2024
• Study Completion: May 7, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

US (1)