A Study to Assess Change in How Oral Icalcaprant With Itraconazole Moves Through the Body in Healthy Adult Participants (529 DDI ITZ)

A Phase 1 Open-label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Icalcaprant in Healthy Adult Subjects

This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant in healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Icalcaprant; Drug: Itraconazole (ITZ)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 271617

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

• History of any clinically significant sensitivity or allergy to any medication or food.
• Exposure to icalcaprant within the past 90 days.
• History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• 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: Icalcaprant with Itraconazole; Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days.	Drug: Icalcaprant; Oral capsule; Other Names: ABBV-1354; CVL-354; Drug: Itraconazole (ITZ); Oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Icalcaprant	Cmax of Icalcaprant	Up to approximately 14 days
Time to Cmax (Tmax) of Icalcaprant	Tmax of Icalcaprant	Up to approximately 14 days
Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant	Beta of Icalcaprant	Up to approximately 14 days
Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant	T1/2 of Icalcaprant	Up to approximately 14 days
Area under the plasma concentration-time curve (AUC) of Icalcaprant	AUC of Icalcaprant	Up to approximately 14 days
Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant	AUCt of Icalcaprant	Up to approximately 14 days
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant	AUCinf of Icalcaprant	Up to approximately 14 days
Number of Participants with Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study	Up to approximately 47 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Actual): January 13, 2025
• Study Completion (Actual): January 13, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteer; Itraconazole; ABBV-1354; CVL-354; Icalcaprant
• 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: M25-529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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