This is an open-label study to assess the absorption, metabolism, excretion, and mass balance of a single oral dose of carbon-14 (\[14C\])-ALXN2050 in healthy adult males.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
9
A single dose of 200 milligrams (\~85 microcuries) \[14C\]-ALXN2050 will be administered orally.
Clinical Trial Site
Lincoln, Nebraska, United States
Mass Balance Recovery In Urine And Feces After a Single Oral Dose Of [14C]-ALXN2050
Mass balance will be assessed by evaluating total radioactivity recovery and the percent of the radioactive dose excreted in the urine and feces. Mass balance will be calculated as a sum of the percent of the total radioactivity recovered in urine and feces plus any radioactivity dose lost due to emesis (if any occurred) relative to the administered radioactivity dose.
Time frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Plasma Pharmacokinetics (PK) Of Total Radioactivity After A Single Oral Dose Of [14C]-ALXN2050: Area Under The Concentration-time Curve From Time 0 Extrapolated To Infinity (AUC0-inf)
Time frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-ALXN2050: Area Under The Concentration Versus Time Curve, From Time 0 To The Time Of The Last Measurable Concentration (AUC0-last)
Time frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-ALXN2050: Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-ALXN2050: Time To Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: AUC0-inf
Time frame: Up to 168 hours postdose
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: AUC0-last
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 168 hours postdose
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: Cmax
Time frame: Up to 168 hours postdose
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: Tmax
Time frame: Up to 168 hours postdose
Percentage Of Total Radioactivity Detected For Each ALXN2050 Metabolite in Plasma, Urine, And Feces
ALXN2050 metabolic profiling in plasma, urine, and feces will be performed in samples containing sufficient amounts of radioactivity. The percent of dose represented by each of the metabolites will be calculated using the radioactivity concentration equivalent data combined with the metabolic profiling data. The percentage of each identified metabolite to total radioactivity in plasma will be estimated based on plasma metabolic profiling data.
Time frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Number Of Participants Receiving A Single Oral Administration Of [14C]-ALXN2050 With Treatment-emergent Adverse Events
Time frame: Day 1 (after dosing) through follow-up (30 [+/- 2] days after dosing on Day 1