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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06887010

Enrollment

Registered

2025-03-20

Start date

2025-03-25

Completion date

2025-09-16

Last updated

2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer

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

Interventions

DRUGABBV-101

Oral: Tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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
Maximum Observed Plasma Concentration (Cmax) of ABBV-101	Up to approximately 21 days	Maximum observed plasma concentration (Cmax) of ABBV-101
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026