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| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
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The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of ACH-0144471 (danicopan) in participants with hepatic impairment (HI) as compared to healthy matched participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Healthy Match | Experimental | Single 200-milligram (mg) dose of danicopan on Day 1 in healthy participants (matched control group with normal hepatic function). |
|
| Part 1: Moderate HI | Experimental | Single 200-mg dose of danicopan on Day 1 in participants with moderate HI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danicopan | Drug | Oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Plasma Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan | Up to 72 hours postdose | |
| Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of Danicopan | Up to 72 hours postdose | |
| Maximum Observed Plasma Concentration (Cmax) Of Danicopan | Up to 72 hours postdose | |
| Time To Maximum Observed Plasma Concentration (Tmax) Of Danicopan | 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) |
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Key Inclusion Criteria:
HI Participants:
Healthy Participants:
Key Exclusion Criteria:
HI Participants:
Healthy Participants:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Miami | Florida | 33136 | United States | ||
| Clinical Trial Site |
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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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This study was to be conducted sequentially in 2 parts.
Part 1: Participants with moderate HI (based on Child-Pugh scores) were compared to demographically matched participants with normal hepatic function.
Following a review of PK and safety data from Part 1, a decision was to be made by the principle investigators and the sponsor whether to conduct Part 2 of this study, which was planned to enroll participants with severe and mild HI.
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| Orlando |
| Florida |
| 32809 |
| United States |
| 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 |