Clinical Trial Site
Tempe, Arizona, 85283, United States
NCT Number: NCT04609696
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Tempe, Arizona, 85283, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Danicopan (200 milligrams) will be administered orally on Day 1.
Other names: ALXN2040, ACH-0144471 (formerly)
Danicopan (200 milligrams) will be administered orally on Day 1.
Other names: ALXN2040, ACH-0144471 (formerly)
Danicopan (200 milligrams) will be administered orally on Day 1.
Other names: ALXN2040, ACH-0144471 (formerly)
Time frame: Up to 72 hours postdose
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
Time frame: Up to 72 hours postdose
Time frame: Up to 72 hours postdose
Time frame: Up to 72 hours postdose
Time frame: Up to 72 hours postdose
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
Time frame: Up to 72 hours postdose
Time frame: Up to 72 hours postdose
Time frame: Up to 72 hours postdose
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Alexion Pharmaceuticals, Inc.
Industry
A 2-Part, Open-Label, Randomized, Single-Dose, 3-Period Crossover, Phase 1, Relative Bioavailability, and Food Effect Study, Comparing Different Formulations of Danicopan in Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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