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| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
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This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (200 milligrams [mg], 600 mg, 1200 mg, 2400 mg) and dose-matched placebo were administered under fasted and fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 200 mg | Experimental | All participants (fasted) received either 200 mg of danicopan as a single oral dose or dose-matched placebo. |
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| Group 2: 600 mg | Experimental | All participants (fasted) received either 600 mg of danicopan as a single oral dose or dose-matched placebo. |
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| Group 3: 1200 mg | Experimental | All participants (fasted) received either 1200 mg of danicopan as a single oral dose or dose-matched placebo. |
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| Group 4: 2400 mg | Experimental | All participants (fasted) received either 2400 mg of danicopan administered as 2 single doses of 1200 mg each, 12 hours apart, or dose-matched placebo. |
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| Group 5: 1200 mg | Experimental | All participants (fed) received either 1200 mg of danicopan as a single oral dose or dose-matched placebo. |
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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 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of Danicopan Under Both Fed And Fasted Conditions | Up to 144 hours postdose | |
| Maximal Plasma Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions | Up to 144 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31573880 | Result | Wiles JA, Galvan MD, Podos SD, Geffner M, Huang M. Discovery and Development of the Oral Complement Factor D Inhibitor Danicopan (ACH-4471). Curr Med Chem. 2020;27(25):4165-4180. doi: 10.2174/0929867326666191001130342. |
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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 |
|
| Time To Reach The Maximal Plasma Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions | Up to 144 hours postdose |
| Relationship Between Alternative Pathway Inhibition And Danicopan Plasma Concentrations | Up to 144 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 |