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Completed

NCT Number: NCT06887010

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

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

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 275921

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-101

Drug

Oral: Tablet

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: 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

  2. Maximum Observed Plasma Concentration (Cmax) of ABBV-101

    Time frame: Up to approximately 21 days

    Maximum observed plasma concentration (Cmax) of ABBV-101

  3. Time to Cmax (Tmax) of ABBV-101

    Time frame: Up to approximately 21 days

    Tmax of ABBV-101

  4. Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-101

    Time frame: Up to approximately 21 days

    AUC of ABBV-101

  5. Terminal Phase Elimination Half-life (t1/2) of ABBV-101

    Time frame: Up to approximately 21 days

    Terminal phase elimination of half-life (t1/2) of ABBV-101

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Study to Assess the Effect of Food on ABBV-101 Pharmacokinetics When Administered as an Oral ABBV-101 Tablet Formulation in Healthy Volunteers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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