A Mass Balance Study of Oral [14C] ABBV-932 in Healthy Adult Male Participants

May 29, 2026 updated by: AbbVie

Mass Balance Study of [14C] ABBV-932 Following Single Oral Dose Administration in Healthy Male Volunteers

The main objective of this study is to assess the safety and tolerability of ABBV-932 in healthy adult male participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728 NZ
        • Recruiting
        • ICON Clinical Research /ID# 270490

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Body Mass Index (BMI) ≥ 18.0 to ≤ 29.9.0 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.
  • Male participant who is not considering fathering a child or donating sperm during the study and for 100 days after the study drug administration
  • A condition of general good health, based upon the results of a medical history, physical exam

Exclusion Criteria:

  • Has not participated in another [14C] absorption, distribution, metabolism, excretion (ADME) study with a radiodose above 0.1 MBq in the period of 12 months prior to screening.
  • Use of any medications/products known to alter drug absorption, metabolism, or excretion processes, within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.
  • Prior exposure to ABBV-932 or cariprazine within the past 90 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABBV-932
Participants will receive a single oral dose of ABBV-932 on day 1.
Drug: ABBV-932
Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax) of ABBV-932
Time Frame: Up to approximately 86 days
Cmax of ABBV-932
Up to approximately 86 days
Time to Cmax (Tmax) of ABBV-932
Time Frame: Up to approximately 86 days
Tmax of ABBV-932
Up to approximately 86 days
Terminal phase elimination rate constant (λz) of ABBV-932
Time Frame: Up to approximately 86 days
Terminal phase elimination rate constant (λz) of ABBV-932
Up to approximately 86 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
Time Frame: Up to approximately 86 days
Terminal phase elimination half-life of ABBV-932
Up to approximately 86 days
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
Time Frame: Up to approximately 86 days
AUCt of ABBV-932
Up to approximately 86 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
Time Frame: Up to approximately 86 days
AUCinf of ABBV-932
Up to approximately 86 days
Number of Participants Experiencing Adverse Events
Time Frame: Up to approximately 103 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.
Up to approximately 103 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M24-991

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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