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

Phase 1

Recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: Icalcaprant; Drug: Itraconazole (ITZ)

• Registration Number: NCT06722430
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-11-13
• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

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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.].

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icalcaprant with Itraconazole	Icalcaprant	Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days.
Icalcaprant with Itraconazole	Itraconazole (ITZ)	Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days.

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of Icalcaprant	Up to approximately 14 days	Cmax of Icalcaprant
Time to Cmax (Tmax) of Icalcaprant	Up to approximately 14 days	Tmax of Icalcaprant
Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant	Up to approximately 14 days	Beta of Icalcaprant
Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant	Up to approximately 14 days	T1/2 of Icalcaprant
Area under the plasma concentration-time curve (AUC) of Icalcaprant	Up to approximately 14 days	AUC of Icalcaprant
Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant	Up to approximately 14 days	AUCt of Icalcaprant
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant	Up to approximately 14 days	AUCinf of Icalcaprant
Number of Participants with Adverse Events (AEs)	Up to approximately 47 days	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

Trial Locations

Locations (1)

Acpru /Id# 271617; 🇺🇸 Grayslake, Illinois, United States