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| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
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This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan (ACH-0144471) compared to demographically-matched healthy participants with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Matched Control Group Of Healthy Participants | Experimental | Participants received a single 200-milligram (mg) treatment on Day 1. |
|
| Group 2: Severe RI And Not On Dialysis | Experimental | Participants received a single 200-mg treatment on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danicopan | Drug | Oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Treatment-emergent Adverse Events | Day 1 through Day 10 (+/- 2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of Danicopan | Up to 72 hours postdose | |
| Maximum Observed Plasma Concentration (Cmax) Of Danicopan | Up to 72 hours postdose |
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Key Inclusion Criteria:
Participants with RI must have met the following additional criteria to be enrolled in this study
Healthy matched control participants with normal renal function must have met the following additional criteria to be enrolled in this study
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Miami | Florida | 33014 | United States | ||
| Clinical Trial Site |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000718467 | danicopan |
| 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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| Time To Reach The Maximum Observed Plasma Concentration (Tmax) Of Danicopan | Up to 72 hours postdose |
| Alternative Pathway Activity As Measured By Wieslab Assay | Up to 72 hours postdose |
| Change From Baseline In Plasma Bb Fragment Of Complement Factor B Concentration | Baseline, Up to 72 hours postdose |
| Change From Baseline In Complement Factor D Concentration | Baseline, Up to 72 hours postdose |
| Orlando |
| Florida |
| 32809 |
| United States |
| Clinical Trial Site | Minneapolis | Minnesota | 55404 | United States |
| Clinical Trial Site | Saint Paul | Minnesota | 55114 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| 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 |