A Phase 1 Study to Assess the Effect of Itraconazole on ABBV-722 in Healthy Adult Participants

May 15, 2026 updated by: AbbVie

A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics, Safety, and Tolerability of ABBV-722 in Healthy Adult Subjects

The objective of this study is to assess the effect of repeated doses of itraconazole on the single dose pharmacokinetics (PK) of ABBV-722.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Recruiting
        • Acpru /Id# 282143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Laboratory values meet the criteria specified in the protocol.
  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

  • History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.
  • Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study treatment administration.
  • Use of tobacco- or nicotine-containing products within 3 months (90 days) prior to the first dose of study treatment.
  • Participant has prior exposure to ABBV-722 within 90 days prior to the first dose of study treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Period 1 & 2
In Period 1, participants will receive a single dose of ABBV-722. In Period 2, participants will receive multiple daily doses of Itraconazole and a single dose of ABBV-722.
Drug: Itraconazole
Oral Capsule
Drug: ABBV-722
Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of ABBV-722
Time Frame: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Cmax of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Time to Cmax (Tmax) of ABBV-722
Time Frame: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Tmax of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-722
Time Frame: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
AUCt of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-722
Time Frame: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
AUCinf of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Terminal Phase Elimination Rate Constant (β) of ABBV-722
Time Frame: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
β of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722
Time Frame: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
t1/2 of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Number of Participants with Adverse Events (AEs)
Time Frame: Up to Approximately 45 Days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to Approximately 45 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 5, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 7, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M25-294

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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