Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003525-15 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
Not provided
Not provided
Not provided
The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danicopan Modified Release Prototype Tablets | Experimental | Participants received danicopan once each period as a single oral dose as follows: Period 1: Danicopan Modified Release Prototype 1 under fasted conditions. Period 2: Danicopan Modified Release Prototype 2 under fasted conditions. Period 3: Danicopan Modified Release Prototype 3 under fasted conditions. Period 4: Danicopan Modified Release Prototype 2 under fed conditions. There was a washout period of at least 14 days between each danicopan dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danicopan Modified Release Prototype 1 | Drug | Danicopan (400 milligrams [mg]) oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time To Maximum Observed Concentration (Tmax) Of Danicopan After Treatment With Each Prototype Formulation | Up to 72 hours postdose | |
| Maximum Observed Concentration (Cmax) Of Danicopan After Treatment With Each Prototype Formulation | Up to 72 hours postdose | |
| Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan After Treatment With Each Prototype Formulation | Up to 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Experiencing Treatment-emergent Adverse Events | Day 1 (postdose) through follow-up visit (10 [+/- 2] days after last study drug administration) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion/exclusion criteria may apply, per protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Ruddington | Nottingham | NG111 6JS | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Danicopan Modified Release Prototype 2 | Drug | Danicopan (400 mg) oral tablet. |
|
|
| Danicopan Modified Release Prototype 3 | Drug | Danicopan (800 mg) oral tablet. |
|
|
| 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 |