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Active, Not Recruiting

NCT Number: NCT07071532

A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Healthy Adult Participants

This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in healthy Adults participants.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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# 276951

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. 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.
  • History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia - Suicide Severity Rating Scale (C-SSRS).

Treatment and study plan

ABBV-932

Drug

Oral Capsule

Itraconazole

Drug

Oral Capsule

Other names: ITZ

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCAR

    Time frame: Up to approximately 29 days

    Cmax of ABBV-932 and active metabolites DCAR and DDCAR

  2. Time to Cmax (Tmax) of ABBV-932 and active metabolites DCAR and DDCAR

    Time frame: Up to approximately 29 days

    Tmax of ABBV-932 and active metabolites DCAR and DDCAR

  3. Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932 and active metabolites DCAR and DDCAR

    Time frame: Up to approximately 29 days

    Ctrough of ABBV-932 and active metabolites DCAR and DDCAR

  4. Apparent terminal phase elimination rate constant (β) of ABBV-932 and active metabolites DCAR and DDCAR

    Time frame: Up to approximately 29 days

    (β) of ABBV-932 and active metabolites DCAR and DDCAR

  5. Terminal Phase Elimination Half-Life (t1/2) of ABBV-932 and active metabolites DCAR and DDCAR

    Time frame: Up to approximately 29 days

    Terminal phase elimination half-life of ABBV-932 and active metabolites DCAR and DDCAR

  6. Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932 and active metabolites DCAR and DDCAR

    Time frame: Up to approximately 29 days

    AUCt of ABBV-932 and active metabolites DCAR and DDCAR

  7. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932 and active metabolites DCAR and DDCAR

    Time frame: Up to approximately 29 days

    AUCinf of ABBV-932 and active metabolites DCAR and DDCAR

  8. Number of Participants Experiencing Adverse Events

    Time frame: Up to approximately 61 days

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of ABBV-932 in Healthy Adult Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2025
Registry last updated
Sep 10, 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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