A Phase 1 Study of a Tablet Form of ABBV-722 Taken With and Without Food in Healthy Adult Participants

A Phase 1 Study to Evaluate the Pharmacokinetics of a Tablet Formulation of ABBV-722 and the Effect of Food on Its Bioavailability in Healthy Adult Subjects

The objective of this study is to evaluate the PK of a tablet formulation of ABBV-722 under fasted conditions and the effect of food on its bioavailability after administration of single doses

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ABBV-722

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 279291

Participation Criteria

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 drug.
• Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration.
• Use of tobacco or nicotine-containing products within 90 days prior to the first dose of study drug.
• Prior exposure to ABBV-722 within 90 days prior to the first dose of study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period 1: Single Dose A; Single dose will be administered under fasted conditions	Drug: ABBV-722; Oral Tablet
Experimental: Period 2: Single Dose A; Single dose will be administered under fed (high-fat meal) conditions	Drug: ABBV-722; Oral Tablet
Experimental: Period 3: Single Dose B; Single dose will be administered under fasted conditions	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	Maximum observed plasma concentration (Cmax) of ABBV-722	Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Time to Cmax (Tmax) of ABBV-722	Time to Cmax (Tmax) of ABBV-722	Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Terminal Phase Elimination Rate Constant (β) of ABBV-722	Terminal phase elimination rate constant of ABBV-722	Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722	Terminal phase elimination half-life of ABBV-722	Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-722	Area under the plasma concentration-time curve from time 0 to the time of last measurable concentration (AUCt) of ABBV-722	Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-722	Area under the plasma concentration-time curve from time 0 to infinite time (AUCinf) of ABBV-722	Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Number of Participants with Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to 57 Days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Actual): March 23, 2026
• Study Completion (Actual): March 23, 2026

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: M25-432

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.: Yes