A Study to Assess How Food Affects the Movement of Oral ABBV-101 Through the Body of Healthy Adult Participants

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ABBV-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06887010

M25-721

Details and patient eligibility

About

This study will assess the effect of food (high fat) on oral ABBV-101 and how ABBV-101 moves through the body in healthy adult participants

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion criteria

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
• 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 90 days prior to the first dose of study treatment.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

ABBV-101: Sequence 1

Experimental group

Description:

Participants will receive ABBV-101 under fasting conditions in Period 1 and will receive ABBV-101 under non-fasting conditions in Period 2

Treatment:

Drug: ABBV-101

ABBV-101: Sequence 2

Experimental group

Description:

Participants will receive ABBV-101 under non-fasting conditions in Period 1 and will receive ABBV-101 under fasting conditions in Period 2.

Treatment:

Drug: ABBV-101