Recruiting NCT07599761

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

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: ABBV-722, Itraconazole.
Who it may be relevant to: Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

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]
Time to Cmax (Tmax) of ABBV-722 [Time frame: Up to Day 8 in Period 1 and Up to Day 14 in Period 2]
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]
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]
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]
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]
Number of Participants with Adverse Events (AEs) [Time frame: Up to Approximately 45 Days]

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).

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

United States · 1 center

NCT: NCT07599761 · M25-294