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

NCT07599761 | Recruiting Phase 1 FDA Drug

• 1 other identifier: M25-294
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax) of ABBV-722

  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

  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

  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

  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

  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

  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)

  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

Study Arms (1)

Period 1 & 2

EXPERIMENTAL

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: ABBV-722; Drug: Itraconazole

Interventions

ABBV-722 DRUG

Oral Tablet

Period 1 & 2

Itraconazole DRUG

Oral Capsule

Period 1 & 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 282143

Grayslake, Illinois, 60030, United States

RECRUITING

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

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: May 7, 2026
• First Posted: May 20, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)