Assessing how food affects the movement of ABBV-101 in healthy adults
A Study to Assess the Effect of Food on ABBV-101 Pharmacokinetics When Administered as an Oral ABBV-101 Tablet Formulation in Healthy Volunteers
This study tests how eating high-fat food affects the way a new drug, ABBV-101, moves through the body in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 1 site (Grayslake, Illinois) |
| Trial ID | NCT06887010 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of high-fat food on the absorption and movement of oral ABBV-101 in healthy adult participants. It aims to understand how food influences the pharmacokinetics of the drug, which is crucial for determining optimal dosing and administration guidelines. Participants will undergo assessments to ensure they meet health criteria and will be monitored throughout the study to gather data on the drug's behavior in the body.
Who should consider this trial
Good fit: Ideal candidates are healthy adults with a BMI between 18.0 and 32.0 kg/m².
Not a fit: Patients with significant medical conditions or those who have recently consumed certain foods or substances may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into how food affects drug absorption, leading to improved dosing recommendations for future treatments.
How similar studies have performed: Other studies have shown success in understanding food-drug interactions, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Grayslake, Illinois
- Acpru /Id# 275921 — Grayslake, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.