A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration
- Registration Number
- NCT05995366
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 7
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABBV-903 ABBV-903 Participants will receive ABBV-903 on Day 1.
- Primary Outcome Measures
Name Time Method Time to Cmax (peak time, Tmax) of ABBV-903 Up to Day 16 Tmax of ABBV-903 will be assessed.
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of ABBV-903 Up to Day 16 AUC0-t of ABBV-903 will be assessed.
AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903 Up to Day 16 AUC0-inf of ABBV-903 will be assessed.
Maximum observed concentration (Cmax) of ABBV-903 Up to Day 16 Cmax of ABBV-903 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-903 Up to Day 16 Terminal phase elimination half-life (t1/2) will be assessed.
Number of Participants with Adverse Events (AEs) Baseline to Day 46 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit Inc. /ID# 253962
🇺🇸Madison, Wisconsin, United States