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

Phase 1

Active, not recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: ABBV-101

• Registration Number: NCT06887010
• Lead Sponsor: AbbVie

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-14
• Study First Posted: 2025-03-20
• Study Start: 2025-03-25
• Status Verified: 2025-08
• Primary Completion: 2025-08
• Study Completion: 2025-08-01
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ABBV-101: Sequence 1	ABBV-101	Participants will receive ABBV-101 under fasting conditions in Period 1 and will receive ABBV-101 under non-fasting conditions in Period 2
ABBV-101: Sequence 2	ABBV-101	Participants will receive ABBV-101 under non-fasting conditions in Period 1 and will receive ABBV-101 under fasting conditions in Period 2.

Primary Outcome Measures

Name	Time	Method
Time to Cmax (Tmax) of ABBV-101	Up to approximately 21 days	Tmax of ABBV-101
Number of Participants Experiencing Adverse Events	Up to approximately 45 days	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
Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-101	Up to approximately 21 days	AUC of ABBV-101
Terminal Phase Elimination Half-life (t1/2) of ABBV-101	Up to approximately 21 days	Terminal phase elimination of half-life (t1/2) of ABBV-101
Maximum Observed Plasma Concentration (Cmax) of ABBV-101	Up to approximately 21 days	Maximum observed plasma concentration (Cmax) of ABBV-101

Trial Locations

Locations (1)

Acpru /Id# 275921; 🇺🇸 Grayslake, Illinois, United States