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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12616001017415 | Registry Identifier | ANZCTR |
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| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
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This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule [LFC]) in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Sequence 1 | Experimental | Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows: Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 3: Danicopan as a tablet under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. |
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| Group 1: Sequence 2 | Experimental | Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows: Period 1: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 2: Danicopan as a tablet under fasted conditions. Period 3: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. |
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| Group 1: Sequence 3 | Experimental | Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows: Period 1: Danicopan as a tablet under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. Period 3: Danicopan as a tablet under fed (medium-fat meal) conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. |
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| Group 2: Sequence 1 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danicopan - Tablet | Drug | Oral tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations | Up to 96 hours postdose | |
| PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations | Up to 96 hours postdose | |
| PK: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-Inf) Of Danicopan After Treatment With Each Of The Three Formulations | Up to 96 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions | Up to 96 hours postdose | |
| PK: Tmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions | Up to 96 hours postdose |
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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 |
| 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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Group 1 followed a 3-treatment, 3-period crossover study design. Group 2 followed a 2-treatment, 2-period crossover study design.
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Participants received danicopan once each period as a single dose under fasted conditions as follows:
Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a softgel capsule under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
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| Group 2: Sequence 2 | Experimental | Participants received danicopan once each period as a single dose under fasted conditions as follows: Period 1: Danicopan as a softgel capsule under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. |
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| Danicopan - Softgel | Drug | Oral softgel capsule. |
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| Danicopan - LFC | Drug | Oral LFC. |
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| PK: AUC0-inf Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions | Up to 96 hours postdose |
| Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation | Day 1 through Day 39 |
| 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 |