A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants

Mass Balance Study of [14C] ABBV-1354 (Icalcaprant) in Healthy Male Subjects Following Single Oral Dose Administration

This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: ABBV-1354

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Fortrea Clinical Research Unit Inc /ID# 277011

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male participants are eligible to participate if they agree to the following from Study Day 1 and for at least 93 days after the last dose of study treatment:
• Refrain from donating sperm

PLUS, either:

- Practice true abstinence, defined as: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.

OR

• Use a male condom with spermicide (even with a successful vasectomy) with female partner who also uses a highly effective contraceptive method with a failure rate of < 1% per year (when used consistently and correctly).

AND

• Advise of the benefit for a female partner to use a highly effective method of contraception (as a condom may break or leak) if having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
• BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. 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), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
• History of any clinically significant sensitivity or allergy to any medication or food.
• History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABBV-1354; Participants will receive a single dose of oral ABBV-1354 and followed 30 days post dose.	Drug: ABBV-1354; Oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs)	An adverse event (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 32 days
Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements	Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.	Up to approximately 15 days
Change From Baseline in Electrocardiograms (ECGs)	12-lead resting ECG will be recorded.	Up to approximately 15 days
Number of Participants with Abnormal Change in Physical Examinations	Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.	Up to approximately 15 days
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed	Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.	Up to approximately 15 days
Maximum observed concentration (Cmax) of ABBV-1354	Cmax of ABBV-1354 will be assessed.	Up to approximately 15 days
Time to Cmax (peak time, Tmax) of ABBV-1354	Max of ABBV-1354 will be assessed.	Up to approximately 15 days
Terminal phase elimination half-life (t1/2) of ABBV-1354	Terminal phase elimination half-life (t1/2) of ABBV-1354 will be assessed.	Up to approximately 15 days
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-1354	AUCt of ABBV-1354 will be assessed.	Up to approximately 15 days
Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-1354	AUCinf of ABBV-1354 will be assessed.	Up to approximately 15 days
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu)	Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed.	Up to approximately 15 days
Percent of ABBV-1354 excreted in the urine	Percent excreted = 100 × (Aeu/dose).	Up to approximately 15 days
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu)	Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed.	Up to approximately 15 days
Percent of ABBV-1354 radioactivity excreted in the feces	Percent excreted = 100 × (Aeu/dose).	Up to approximately 15 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Actual): December 9, 2025
• Study Completion (Actual): December 9, 2025

Study Registration Dates

• First Submitted: October 17, 2025
• First Submitted That Met QC Criteria: October 17, 2025
• First Posted (Estimated): October 21, 2025

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteer; ABBV-1354
• Other Study ID Numbers: M25-571

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No