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Completed

NCT Number: NCT07219017

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

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

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Key information

Conditions

Healthy Volunteer

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc /ID# 277011

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.].

Treatment and study plan

ABBV-1354

Drug

Oral solution

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 32 days

    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.

  2. Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements

    Time frame: Up to approximately 15 days

    Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

  3. Change From Baseline in Electrocardiograms (ECGs)

    Time frame: Up to approximately 15 days

    12-lead resting ECG will be recorded.

  4. Number of Participants with Abnormal Change in Physical Examinations

    Time frame: Up to approximately 15 days

    Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.

  5. Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed

    Time frame: Up to approximately 15 days

    Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

  6. Maximum observed concentration (Cmax) of ABBV-1354

    Time frame: Up to approximately 15 days

    Cmax of ABBV-1354 will be assessed.

  7. Time to Cmax (peak time, Tmax) of ABBV-1354

    Time frame: Up to approximately 15 days

    Max of ABBV-1354 will be assessed.

  8. Terminal phase elimination half-life (t1/2) of ABBV-1354

    Time frame: Up to approximately 15 days

    Terminal phase elimination half-life (t1/2) of ABBV-1354 will be assessed.

  9. Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-1354

    Time frame: Up to approximately 15 days

    AUCt of ABBV-1354 will be assessed.

  10. Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-1354

    Time frame: Up to approximately 15 days

    AUCinf of ABBV-1354 will be assessed.

  11. Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu)

    Time frame: Up to approximately 15 days

    Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed.

  12. Percent of ABBV-1354 excreted in the urine

    Time frame: Up to approximately 15 days

    Percent excreted = 100 × (Aeu/dose).

  13. Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu)

    Time frame: Up to approximately 15 days

    Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed.

  14. Percent of ABBV-1354 radioactivity excreted in the feces

    Time frame: Up to approximately 15 days

    Percent excreted = 100 × (Aeu/dose).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2025
Registry last updated
Jan 5, 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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