A Study to Assess Change in How Oral Icalcaprant With Itraconazole Moves Through the Body in Healthy Adult Participants

NCT06722430 | Completed Phase 1

• 1 other identifier: M25-529
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; Icalcaprant; Itraconazole; ABBV-1354; CVL-354

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Icalcaprant with Itraconazole

EXPERIMENTAL

Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days.

Drug: Icalcaprant; Drug: Itraconazole (ITZ)

Interventions

Icalcaprant DRUG

Oral capsule

Also known as: ABBV-1354, CVL-354

Icalcaprant with Itraconazole

Itraconazole (ITZ) DRUG

Oral capsule

Icalcaprant with Itraconazole

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 271617

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: November 13, 2024
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)