Status:
COMPLETED
A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteer
Eligibility:
MALE
18-60 years
Phase:
PHASE1
Brief Summary
This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants.
Eligibility Criteria
Inclusion
- 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
- 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 \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT07219017
Start Date
October 15 2025
End Date
December 9 2025
Last Update
January 5 2026
Active Locations (1)
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1
Fortrea Clinical Research Unit Inc /ID# 277011
Madison, Wisconsin, United States, 53704