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

NCT06887010 | Completed Phase 1

• 1 other identifier: M25-721
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

ABBV-101: Sequence 1

EXPERIMENTAL

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

ABBV-101: Sequence 2

EXPERIMENTAL

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

Interventions

ABBV-101 DRUG

Oral: Tablet

ABBV-101: Sequence 1; ABBV-101: Sequence 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 275921

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: March 25, 2025
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)