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Completed

NCT Number: NCT07361367

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 279291

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-722

Drug

Oral Tablet

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of ABBV-722

    Time frame: Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)

    Maximum observed plasma concentration (Cmax) of ABBV-722

  2. Time to Cmax (Tmax) of ABBV-722

    Time frame: 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

  3. Terminal Phase Elimination Rate Constant (β) of ABBV-722

    Time frame: 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 of ABBV-722

  4. Terminal Phase Elimination Half-Life (t1/2) of ABBV-722

    Time frame: 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 of ABBV-722

  5. 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 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 the time of last measurable concentration (AUCt) of ABBV-722

  6. Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-722

    Time frame: 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

  7. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 57 Days

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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