A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration
- Registration Number
- NCT06278766
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-552 in healthy, male volunteers following administration of a single oral dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
- Male volunteers in general good health at Screening.
- Considering fathering a child or donating sperm during the study and for 100 days after study drug administration.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABBV-552 ABBV-552 Participants will receive ABBV-552 on Day 1.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) Up to approximately 30 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.
Maximum observed concentration (Cmax) of ABBV-552 Up to approximately Day 15 Cmax of ABBV-552 will be assessed.
Time to Cmax (peak time, Tmax) of ABBV-552 Up to approximately 15 days Tmax of ABBV-552 will be assessed.
Terminal phase elimination rate constant (λz) of ABBV-552 Up to approximately 15 days Terminal phase elimination rate constant (λz) of ABBV-552 will be assessed.
Terminal phase elimination half-life (t1/2) of ABBV-552 Up to approximately 15 days Terminal phase elimination half-life (t1/2) of ABBV-552 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-552 Up to approximately 15 days AUCt of ABBV-552 will be assessed.
Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552 Up to approximately 15 days AUCinf of ABBV-552 will be assessed.
Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) Up to approximately 15 days Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) will be assessed.
Percent of ABBV-552 excreted in the urine Up to approximately 15 days Percent excreted = 100 × (Aeu/dose).
Renal clearance ABBV-552 (CLr) Up to approximately 15 days Renal clearance of ABBV-552 will be assessed.
Amount of ABBV-552 excreted in the feces over the sampling period (Aef) Up to approximately 15 days Amount of ABBV-552 excreted in the feces over the sampling period (Aef) will be assessed.
Percent radioactivity excreted in the feces Up to approximately 15 days Percent excreted = 100 × (Aef/dose).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit Inc /ID# 262684
🇺🇸Madison, Wisconsin, United States