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

Launched by ABBVIE · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to understand how food, particularly high-fat meals, affects the way an experimental drug called ABBV-101 moves through the body. The study will involve healthy adult volunteers, who will take the drug and then have its effects monitored after eating. This helps researchers learn how food can influence the effectiveness and absorption of the medication.

To participate in this trial, you should be a healthy adult between the ages of 18 and 75, with a body mass index (BMI) between 18.0 and 32.0. Before joining, you will undergo a medical check-up to ensure you're in good health. It's important to note that participants should not have certain medical conditions, such as serious heart or lung issues, and should avoid specific foods and substances, like alcohol and tobacco, for a certain period before taking the drug. If you decide to join, you can expect to be closely monitored during the study to ensure your safety and gather valuable information about the drug's behavior in the body.

Gender

ALL

Eligibility criteria

• 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.