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

Phase 1

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: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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
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
Time to Cmax (Tmax) of ABBV-101	Up to approximately 21 days	Tmax of ABBV-101
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