A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Healthy Adult Participants

Not Applicable

Recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: ABBV-932; Drug: Itraconazole

• Registration Number: NCT07071532
• Lead Sponsor: AbbVie

Brief Summary

This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in healthy Adults participants.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-08
• Study Start: 2025-07-15
• Study First Posted: 2025-07-17
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2025-11
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Body Mass Index (BMI) ≥ 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 epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
• History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia - Suicide Severity Rating Scale (C-SSRS).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABBV-932 with Itraconazole	ABBV-932	Participants will receive ABBV-932 in Period 1 followed by Itraconalzole in combination with ABBV-932 in Period 2.
ABBV-932 with Itraconazole	Itraconazole	Participants will receive ABBV-932 in Period 1 followed by Itraconalzole in combination with ABBV-932 in Period 2.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCAR	Up to approximately 29 days	Cmax of ABBV-932 and active metabolites DCAR and DDCAR
Time to Cmax (Tmax) of ABBV-932 and active metabolites DCAR and DDCAR	Up to approximately 29 days	Tmax of ABBV-932 and active metabolites DCAR and DDCAR
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932 and active metabolites DCAR and DDCAR	Up to approximately 29 days	Ctrough of ABBV-932 and active metabolites DCAR and DDCAR
Apparent terminal phase elimination rate constant (β) of ABBV-932 and active metabolites DCAR and DDCAR	Up to approximately 29 days	(β) of ABBV-932 and active metabolites DCAR and DDCAR
Terminal Phase Elimination Half-Life (t1/2) of ABBV-932 and active metabolites DCAR and DDCAR	Up to approximately 29 days	Terminal phase elimination half-life of ABBV-932 and active metabolites DCAR and DDCAR
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932 and active metabolites DCAR and DDCAR	Up to approximately 29 days	AUCt of ABBV-932 and active metabolites DCAR and DDCAR
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932 and active metabolites DCAR and DDCAR	Up to approximately 29 days	AUCinf of ABBV-932 and active metabolites DCAR and DDCAR
Number of Participants Experiencing Adverse Events	Up to approximately 61 days	An 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.

Trial Locations

Locations (1)

Acpru /Id# 276951; 🇺🇸 Grayslake, Illinois, United States