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

Not Applicable

Recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: ABBV-1354

• Registration Number: NCT07219017
• Lead Sponsor: AbbVie

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-15
• Study First Submitted: 2025-10-17
• Study First Submitted QC: 2025-10-17
• Last Update Submitted: 2025-10-17
• Study First Posted: 2025-10-21
• Last Update Posted: 2025-10-21
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	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.
Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements	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.
Change From Baseline in Electrocardiograms (ECGs)	Up to approximately 15 days	12-lead resting ECG will be recorded.
Number of Participants with Abnormal Change in Physical Examinations	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.
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed	Up to approximately 15 days	Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Maximum observed concentration (Cmax) of ABBV-1354	Up to approximately 15 days	Cmax of ABBV-1354 will be assessed.
Time to Cmax (peak time, Tmax) of ABBV-1354	Up to approximately 15 days	Max of ABBV-1354 will be assessed.
Terminal phase elimination half-life (t1/2) of ABBV-1354	Up to approximately 15 days	Terminal phase elimination half-life (t1/2) of ABBV-1354 will be assessed.
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-1354	Up to approximately 15 days	AUCt of ABBV-1354 will be assessed.
Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-1354	Up to approximately 15 days	AUCinf of ABBV-1354 will be assessed.
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu)	Up to approximately 15 days	Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed.
Percent of ABBV-1354 excreted in the urine	Up to approximately 15 days	Percent excreted = 100 × (Aeu/dose).
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu)	Up to approximately 15 days	Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed.
Percent of ABBV-1354 radioactivity excreted in the feces	Up to approximately 15 days	Percent excreted = 100 × (Aeu/dose).

Trial Locations

Locations (1)

Fortrea Clinical Research Unit Inc; 🇺🇸 Madison, Wisconsin, United States