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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-ALXN2050 | Experimental | Participants will receive [14C]-ALXN2050. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-ALXN2050 | Drug | A single dose of 200 milligrams (~85 microcuries) [14C]-ALXN2050 will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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) | 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) | 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) | 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 | Up to 168 hours postdose | |
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Participants Receiving A Single Oral Administration Of [14C]-ALXN2050 With Treatment-emergent Adverse Events | Day 1 (after dosing) through follow-up (30 [+/- 2] days after dosing on Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| D020742 | rhoA GTP-Binding Protein |
| ID | Term |
|---|---|
| D020741 | rho GTP-Binding Proteins |
| D020559 | Monomeric GTP-Binding Proteins |
| D019204 | GTP-Binding Proteins |
| D020558 | GTP Phosphohydrolases |
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| Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: AUC0-last |
| Up to 168 hours postdose |
| Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: Cmax | Up to 168 hours postdose |
| Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: Tmax | 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. | Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose |
| D017766 | Acid Anhydride Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D047908 | Intracellular Signaling Peptides and Proteins |