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| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
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This was an open-label study to evaluate the absorption, distribution, metabolism, and excretion of radioactivity in healthy male participants following a single 150-milligram (mg) oral dose of carbon-14 ([14C])-ACH-014447 ([14C])-danicopan) containing approximately 100 microcuries (µCi) of [14C].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-Danicopan | Experimental | Participants were administered a single oral dose of danicopan between 151 and 154 mg (nominal dose of 150 mg), providing approximately 100 μCi of [14C] radiolabel in the form of [14C]-danicopan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-Danicopan | Drug | Liquid-filled capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Cumulative Percentages Of Total Radioactivity Recovered In Urine And Feces Following A Single Oral Dose Of [14C]-Danicopan | Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period | |
| Whole Blood And Plasma Pharmacokinetics (PK) Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Area Under The Concentration-time Curve From Time 0 To The Time Of Last Quantifiable Concentration (AUC0-t) | Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period | |
| Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Area Under The Concentration-time Curve Extrapolated to Infinity (AUC0-inf) | Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period | |
| Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Maximum Observed Concentration (Cmax) | Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period | |
| Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Time To Maximum Observed Concentration (Tmax) | Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period | |
| Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-t | Up to 96 hours postdose | |
| Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-inf | Up to 96 hours postdose | |
| Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Cmax |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Of Total Radioactivity Detected For Each [14C]-Danicopan Metabolite in Plasma, Urine, And Feces | [14C]-Danicopan metabolic profiling in plasma, urine, and feces was performed in samples containing sufficient amounts of radioactivity. The percent of dose represented by each of the metabolites was calculated using the radioactivity concentration equivalent data combined with the metabolic profiling data. The percentage of each identified metabolite to total radioactivity in plasma was estimated based on plasma metabolic profiling data. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Auckland | New Zealand |
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| ID | Term |
|---|---|
| C000718467 | danicopan |
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| Up to 96 hours postdose |
| Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Tmax | Up to 96 hours postdose |
| [14C]-Danicopan Metabolites In Plasma, Urine, And Feces | Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period |
| Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period |
| Incidence Of Treatment-emergent Adverse Events | Day 1 through Day 10 |