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

NCT ID: NCT07219017

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2025-12-09

Brief Summary

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

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

ABBV-1354

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

Group Type: EXPERIMENTAL

ABBV-1354

Intervention Type: DRUG

Oral solution

Interventions

ABBV-1354

Oral solution

Intervention Type: DRUG

Eligibility Criteria

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.].

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Fortrea Clinical Research Unit Inc /ID# 277011

Madison, Wisconsin, United States

Countries

United States

Related Links

https://www.abbvieclinicaltrials.com/study/?id=M25-571

Related Info

Other Identifiers

M25-571

Identifier Type: -

Identifier Source: org_study_id