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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: ABBV-101

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 275921

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABBV-101: Sequence 1; Participants will receive ABBV-101 under fasting conditions in Period 1 and will receive ABBV-101 under non-fasting conditions in Period 2	Drug: ABBV-101; Oral: Tablet
Experimental: ABBV-101: Sequence 2; Participants will receive ABBV-101 under non-fasting conditions in Period 1 and will receive ABBV-101 under fasting conditions in Period 2.	Drug: ABBV-101; Oral: Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events	An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment	Up to approximately 45 days
Maximum Observed Plasma Concentration (Cmax) of ABBV-101	Maximum observed plasma concentration (Cmax) of ABBV-101	Up to approximately 21 days
Time to Cmax (Tmax) of ABBV-101	Tmax of ABBV-101	Up to approximately 21 days
Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-101	AUC of ABBV-101	Up to approximately 21 days
Terminal Phase Elimination Half-life (t1/2) of ABBV-101	Terminal phase elimination of half-life (t1/2) of ABBV-101	Up to approximately 21 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Actual): September 16, 2025
• Study Completion (Actual): September 16, 2025

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteer
• Other Study ID Numbers: M25-721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No