Status:
COMPLETED
A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteer
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the mass balance and safety of \[14C\] ABBV-903 in healthy male volunteers following a single oral dose administration.
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal at Screening and upon initial confinement.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
Exclusion
- History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, Gilbert's Syndrome, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to study drug administration.
- Consider fathering a child or donating sperm during the study and for 94 days after study drug administration.
- Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.
Key Trial Info
Start Date :
August 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05995366
Start Date
August 18 2023
End Date
October 13 2023
Last Update
October 26 2023
Active Locations (1)
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1
Fortrea Clinical Research Unit Inc. /ID# 253962
Madison, Wisconsin, United States, 53704