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This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.
This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent.
On Day 1 of each period, participants will receive a single oral dose of 200 milligrams (mg) danicopan under fasting conditions, 200 mg danicopan under fed conditions, or 400 mg danicopan under fed conditions. Participants will receive each treatment once, according to the randomization schedule. There will be a washout period of at least 7 days between each dose of study intervention.
Safety will be assessed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danicopan 200 mg Fasted | Experimental | Fasting participants will receive a single dose of 200 mg danicopan. |
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| Danicopan 200 mg Fed | Experimental | Fed participants will receive a single dose of 200 mg danicopan. |
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| Danicopan 400 mg Fed | Experimental | Fed participants will receive a single dose of 400 mg danicopan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danicopan | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Participants With Treatment-Emergent Adverse Events | Day 1 (after first dose) through safety follow-up (10 +/- 2 days after last dose) | |
| Area Under The Concentration Versus Time Curve (AUC) Of Danicopan In Both Fed And Fasted States | up to 72 hours postdose | |
| Maximum Observed Concentration (Cmax) Of Danicopan In Both Fed And Fasted States | up to 72 hours postdose | |
| Time To Maximum Observed Concentration (Tmax) Of Danicopan In Both Fed And Fasted States | up to 72 hours postdose | |
| Dose Proportionality Of Danicopan In Fed State Assessed by AUC | up to 72 hours postdose | |
| Dose Proportionality Of Danicopan In Fed State Assessed by Cmax | up to 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Activity Of Danicopan As Measured By Alternative Pathway Wieslab Assay | Blood samples will be collected for measurement of danicopan activity. | up to 72 hours postdose |
| Complement Factor B Fraction b Levels |
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Inclusion Criteria:
Participants who are of Japanese descent defined as:
No clinically significant history or presence of electrocardiogram findings as judged by the Investigator at screening and prior to the first dose of study intervention in Period 1.
Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meters squared, inclusive, with a minimum body weight of 50.0 kg at screening.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Site | Brisbane | Australia |
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| ID | Term |
|---|---|
| C000718467 | danicopan |
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Three-way crossover
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Blood samples will be collected for measurement of complement factor B fraction b levels.
| up to 72 hours postdose |