Clinical Trial Site
Lincoln, Nebraska, 68502, United States
NCT Number: NCT04609670
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.
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Notify Me19 year–55 year
Male
Interventional
Phase 1
Lincoln, Nebraska, 68502, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose of 200 milligrams (~85 microcuries) [14C]-ALXN2050 will be administered orally.
Other names: ALXN2050, ACH-0145228 (formerly)
Time frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
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
Time frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Time frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Time frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Time frame: Up to 168 hours postdose
Time frame: Up to 168 hours postdose
Time frame: Up to 168 hours postdose
Time frame: Up to 168 hours postdose
Time frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
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: Day 1 (after dosing) through follow-up (30 [+/- 2] days after dosing on Day 1
Alexion Pharmaceuticals, Inc.
Industry
A Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-ALXN2050 in Healthy Adult Male Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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