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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Oral Solution
Fortrea Clinical Research Unit Inc /ID# 262684
Madison, Wisconsin, United States
Number of Participants with Adverse Events (AEs)
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.
Time frame: Up to approximately 30 days
Maximum observed concentration (Cmax) of ABBV-552
Cmax of ABBV-552 will be assessed.
Time frame: Up to approximately Day 15
Time to Cmax (peak time, Tmax) of ABBV-552
Tmax of ABBV-552 will be assessed.
Time frame: Up to approximately 15 days
Terminal phase elimination rate constant (λz) of ABBV-552
Terminal phase elimination rate constant (λz) of ABBV-552 will be assessed.
Time frame: Up to approximately 15 days
Terminal phase elimination half-life (t1/2) of ABBV-552
Terminal phase elimination half-life (t1/2) of ABBV-552 will be assessed.
Time frame: Up to approximately 15 days
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552
AUCt of ABBV-552 will be assessed.
Time frame: Up to approximately 15 days
Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552
AUCinf of ABBV-552 will be assessed.
Time frame: Up to approximately 15 days
Amount of ABBV-552 excreted in the urine over the sampling period (Aeu)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) will be assessed.
Time frame: Up to approximately 15 days
Percent of ABBV-552 excreted in the urine
Percent excreted = 100 × (Aeu/dose).
Time frame: Up to approximately 15 days
Renal clearance ABBV-552 (CLr)
Renal clearance of ABBV-552 will be assessed.
Time frame: Up to approximately 15 days
Amount of ABBV-552 excreted in the feces over the sampling period (Aef)
Amount of ABBV-552 excreted in the feces over the sampling period (Aef) will be assessed.
Time frame: Up to approximately 15 days
Percent radioactivity excreted in the feces
Percent excreted = 100 × (Aef/dose).
Time frame: Up to approximately 15 days