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

NCT07219017 | Completed Phase 1 FDA Drug

• 1 other identifier: M25-571
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-1354

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (1)

ABBV-1354

EXPERIMENTAL

Participants will receive a single dose of oral ABBV-1354 and followed 30 days post dose.

Drug: ABBV-1354

Interventions

ABBV-1354 DRUG

Oral solution

ABBV-1354

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc /ID# 277011

Madison, Wisconsin, 53704, United States

Location

Related Links

• Related Info

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: October 17, 2025
• First Posted: October 21, 2025
• Study Start: October 15, 2025
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)