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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ABBV-722

Study type: Interventional

Funder types: Industry

Identifiers

NCT07361367

M25-432

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Period 1: Single Dose A

Experimental group

Description:

Single dose will be administered under fasted conditions

Treatment:

Drug: ABBV-722

Period 2: Single Dose A

Experimental group

Description:

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

Treatment:

Drug: ABBV-722

Period 3: Single Dose B

Experimental group

Description:

Single dose will be administered under fasted conditions

Treatment:

Drug: ABBV-722