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

AbbVie

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ABBV-932

Study type: Interventional

Funder types: Industry

Identifiers

NCT06953934

M24-991

Details and patient eligibility

About

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

Enrollment: 8 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

ABBV-932

Experimental group

Description:

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

Treatment:

Drug: ABBV-932