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

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT06722430

Run by

AbbVie

People needed

12

Starts

2024-11-13

Expected to finish

2025-01-13

Last updated by the study team

2025-01-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.].

Where it is running

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

Full record on ClinicalTrials.gov

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