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This will be an open-label, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants. Part 2 will be a 1-period age-effect study in healthy elderly male participants.
This will be an open-label, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants. Part 2 will be a 1-period age-effect study in healthy elderly male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Sequence 1 | Experimental | Healthy, young, adult participants will receive danicopan once each Period as follows: Period 1: Danicopan administered under fed conditions. Period 2: Danicopan administered under fasted conditions. There will be a washout period of at least 7 days between the dose of danicopan in Period 1 and the dose of danicopan in Period 2. |
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| Part 1: Sequence 2 | Experimental | Healthy, young, adult participants will receive danicopan once each Period as follows: Period 1: Danicopan administered under fasted conditions. Period 2: Danicopan administered under fed conditions. There will be a washout period of at least 7 days between the dose of danicopan in Period 1 and the dose of danicopan in Period 2. |
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| Part 2 | Experimental | Healthy, elderly, male participants will receive a single dose of danicopan under fed conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danicopan | Drug | A single dose of danicopan (200 milligrams) will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of Danicopan Under Both Fed And Fasted Conditions In Healthy Young Adults | Up to 72 hours postdose | |
| Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan Under Both Fed And Fasted Conditions In Healthy Young Adults | Up to 72 hours postdose | |
| Maximum Observed Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults | Up to 72 hours postdose | |
| Time To Maximum Observed Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults | Up to 72 hours postdose | |
| AUC0-t Of Danicopan Under Fed Conditions In Healthy Elderly Males | Up to 72 hours postdose | |
| AUC0-inf Of Danicopan Under Fed Conditions In Healthy Elderly Males | Up to 72 hours postdose | |
| Cmax Of Danicopan Under Fed Conditions In Healthy Elderly Males | Up to 72 hours postdose | |
| Tmax Of Danicopan Under Fed Conditions In Healthy Elderly Males | Up to 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Healthy Young Adults And Healthy Elderly Males With Treatment-emergent Adverse Events | Day 1 (postdose) through follow-up (10 [+/- 2] days after last study drug administration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| C000718467 | danicopan |
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This will be 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover study, and Part 2 will be a 1-period study.
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