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

NCT06953934 | Active Not Recruiting Phase 1

• 1 other identifier: M24-991
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-932

Outcome Measures

Primary Outcomes (7)

• Maximum Plasma Concentration (Cmax) of ABBV-932

  Cmax of ABBV-932

  Up to approximately 86 days

• Time to Cmax (Tmax) of ABBV-932

  Tmax of ABBV-932

  Up to approximately 86 days

• Terminal phase elimination rate constant (λz) of ABBV-932

  Terminal phase elimination rate constant (λz) of ABBV-932

  Up to approximately 86 days

• Terminal Phase Elimination Half-Life (t1/2) of ABBV-932

  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

  AUCt of ABBV-932

  Up to approximately 86 days

• Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932

  AUCinf of ABBV-932

  Up to approximately 86 days

• Number of Participants Experiencing Adverse Events

  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

Study Arms (1)

ABBV-932

EXPERIMENTAL

Participants will receive a single oral dose of ABBV-932 on day 1.

Drug: ABBV-932

Interventions

ABBV-932 DRUG

Oral Capsule

ABBV-932

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

ICON Clinical Research /ID# 270490

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 1, 2025
• Study Start: May 4, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)