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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07599761

Enrollment

Registered

2026-05-20

Start date

2026-05-07

Completion date

2026-09-01

Last updated

2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

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.

Interventions

DRUGABBV-722

Oral Tablet

DRUGItraconazole

Oral Capsule

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximum Observed Plasma Concentration (Cmax) of ABBV-722	Up to Day 8 in Period 1 and Up to Day 14 in Period 2	Cmax of ABBV-722
Time to Cmax (Tmax) of ABBV-722	Up to Day 8 in Period 1 and Up to Day 14 in Period 2	Tmax of ABBV-722
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-722	Up to Day 8 in Period 1 and Up to Day 14 in Period 2	AUCt of ABBV-722
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-722	Up to Day 8 in Period 1 and Up to Day 14 in Period 2	AUCinf of ABBV-722
Terminal Phase Elimination Rate Constant (β) of ABBV-722	Up to Day 8 in Period 1 and Up to Day 14 in Period 2	β of ABBV-722
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722	Up to Day 8 in Period 1 and Up to Day 14 in Period 2	t1/2 of ABBV-722
Number of Participants with Adverse Events (AEs)	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.

Countries

United States

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026