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Active, Not Recruiting

NCT Number: NCT06953934

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

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

Male

Study type

Interventional

Phase

Phase 1

Primary location

ICON Clinical Research /ID# 270490

Groningen, 9728 NZ, Netherlands

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 ≤ 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.

Treatment and study plan

ABBV-932

Drug

Oral Capsule

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of ABBV-932

    Time frame: Up to approximately 86 days

    Cmax of ABBV-932

  2. Time to Cmax (Tmax) of ABBV-932

    Time frame: Up to approximately 86 days

    Tmax of ABBV-932

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 1, 2025
Registry last updated
Jun 29, 2026

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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