NCT07361367

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2026

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

January 15, 2026

Last Update Submit

April 22, 2026

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (3)

Period 1: Single Dose A

EXPERIMENTAL

Single dose will be administered under fasted conditions

Drug: ABBV-722

Period 2: Single Dose A

EXPERIMENTAL

Single dose will be administered under fed (high-fat meal) conditions

Drug: ABBV-722

Period 3: Single Dose B

EXPERIMENTAL

Single dose will be administered under fasted conditions

Drug: ABBV-722

Interventions

ABBV-722DRUG

Oral Tablet

Period 1: Single Dose APeriod 2: Single Dose APeriod 3: Single Dose B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acpru /Id# 279291

Grayslake, Illinois, 60030, United States

Location

Related Links

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

January 15, 2026

Primary Completion

March 23, 2026

Study Completion

March 23, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)