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| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
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This was a multiple ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (75 milligrams [mg], 200 mg, 500 mg, 800 mg) and dose-matched placebo were administered under fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 200 mg | Experimental | All participants under fasted conditions received 200 mg of danicopan or placebo twice daily (BID) over a 14-day period. |
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| Cohort 2: 500 mg | Experimental | All participants under fasted conditions received 500 mg of danicopan or placebo BID over a 14-day period. |
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| Cohort 3: 800 mg | Experimental | All participants under fasted conditions received 800 mg of danicopan or placebo BID over a 14-day period. |
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| Cohort 4: 75 mg | Experimental | All participants under fasted conditions received 75 mg of danicopan or placebo thrice daily (TID) over a 7-day period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danicopan | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), AEs Leading To Discontinuation, And Clinically Significant Laboratory Abnormalities And Electrocardiogram Abnormalities | Day 1 through Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) Of Danicopan | Up to 16 hours postdose | |
| Time To Maximum Observed Plasma Concentration (Tmax) Of Danicopan | Up to 16 hours postdose | |
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Inclusion Criteria:
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 |
| 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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| Placebo | Drug |
|
| Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Danicopan |
| Up to 16 hours postdose |
| Activity Of Danicopan As Measured By Alternative Pathway (AP) Wieslab Assay | Up to 16 hours postdose |
| Relationship Between AP Inhibition And Danicopan Plasma Concentrations | Up to 16 hours 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 |