This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.
For both parts of this study, on Day 1 of each period, participants will receive a single oral dose of danicopan as either the prototype powder-in-capsule (PIC) formulation (1 or 2) under fed conditions, the prototype PIC formulation (1 or 2) under fasting conditions, or the tablet formulation under fed conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Danicopan (200 milligrams) will be administered orally on Day 1.
Danicopan (200 milligrams) will be administered orally on Day 1.
Danicopan (200 milligrams) will be administered orally on Day 1.
Clinical Trial Site
Tempe, Arizona, United States
Relative Bioavailability Of Danicopan Prototype PIC 1 Formulation And Tablet Formulation
The relative bioavailability of the PIC 1 formulation versus the tablet formulation will be measured by the ratio of select pharmacokinetic (PK) parameters: maximum observed plasma concentration (Cmax), area under the concentration-time curve from time of administration to the last measurable concentration (AUC0-t), and area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf).
Time frame: Up to 72 hours postdose
AUC0-inf Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
AUC0-t Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Cmax Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Time to maximum observed plasma concentration (Tmax) Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Relative Bioavailability Of Danicopan Prototype PIC 2 Formulation And Tablet Formulation
The relative bioavailability of the PIC 2 formulation versus the tablet formulation will be measured by the ratio of select PK parameters: Cmax, AUC0-t, and AUC0-inf.
Time frame: Up to 72 hours postdose
AUC0-inf Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
AUC0-t Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
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Time frame: Up to 72 hours postdose
Cmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Tmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Number Of Participants Receiving Prototype PIC 1 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Number Of Participants Receiving Prototype PIC 1 With Treatment-emergent Adverse Events Under Fasted Conditions
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Number Of Participants Receiving Prototype PIC 2 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Number Of Participants Receiving Prototype PIC 2 With Treatment-emergent Adverse Events Under Fasted Conditions
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)