This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Oral solution
Fortrea Clinical Research Unit Inc /ID# 277011
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 32 days
Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Time frame: Up to approximately 15 days
Change From Baseline in Electrocardiograms (ECGs)
12-lead resting ECG will be recorded.
Time frame: Up to approximately 15 days
Number of Participants with Abnormal Change in Physical Examinations
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.
Time frame: Up to approximately 15 days
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Time frame: Up to approximately 15 days
Maximum observed concentration (Cmax) of ABBV-1354
Cmax of ABBV-1354 will be assessed.
Time frame: Up to approximately 15 days
Time to Cmax (peak time, Tmax) of ABBV-1354
Max of ABBV-1354 will be assessed.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to approximately 15 days
Terminal phase elimination half-life (t1/2) of ABBV-1354
Terminal phase elimination half-life (t1/2) of ABBV-1354 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-1354
AUCt of ABBV-1354 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-1354
AUCinf of ABBV-1354 will be assessed.
Time frame: Up to approximately 15 days
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu)
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed.
Time frame: Up to approximately 15 days
Percent of ABBV-1354 excreted in the urine
Percent excreted = 100 × (Aeu/dose).
Time frame: Up to approximately 15 days
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu)
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed.
Time frame: Up to approximately 15 days
Percent of ABBV-1354 radioactivity excreted in the feces
Percent excreted = 100 × (Aeu/dose).
Time frame: Up to approximately 15 days