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NCT Number: NCT07599761

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

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

Recruiting

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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# 282143

Grayslake, Illinois, 60030, United States

Location status: Recruiting

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 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.

Treatment and study plan

ABBV-722

Drug

Oral Tablet

Itraconazole

Drug

Oral Capsule

Primary outcomes

  1. 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

  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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 20, 2026
Registry last updated
May 20, 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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