This was a 3-part study (Part 1, Part 2, Part 3) with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.
This study was conducted to assess the 2-way interaction between danicopan and warfarin (Part 1), bupropion (Part 2), and ethinyl estradiol/norethindrone (EE/NET) as an oral contraceptive (Part 3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
52
Clinical Study Site
Tempe, Arizona, United States
Part 1: Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Single-dose Warfarin Under Multiple Doses Of Danicopan
Time frame: Up to 168 hours postdose
Part 1: Maximum Observed Concentration (Cmax) Of Single-dose Warfarin Under Multiple Doses Of Danicopan
Time frame: Up to 168 hours postdose
Part 1: Time To Maximum Observed Concentration (Tmax) Of Single-dose Warfarin Under Multiple Doses Of Danicopan
Time frame: Up to 168 hours postdose
Part 2: AUC0-inf Of Single-dose Bupropion Under Multiple Doses Of Danicopan
Time frame: Up to 96 hours postdose
Part 2: Cmax Of Single-dose Bupropion Under Multiple Doses Of Danicopan
Time frame: Up to 96 hours postdose
Part 2: Tmax Of Single-dose Bupropion Under Multiple Doses Of Danicopan
Time frame: Up to 96 hours postdose
Part 3: AUC0-inf Of Single-dose EE/NET Under Multiple Doses Of Danicopan
Time frame: Up to 96 hours postdose
Part 3: Cmax Of Single-dose EE/NET Under Multiple Doses Of Danicopan
Time frame: Up to 96 hours postdose
Part 3: Tmax Of Single-dose EE/NET Under Multiple Doses Of Danicopan
Time frame: Up to 96 hours postdose
Part 1: International Normalized Ratio (INR) Of Single-dose Warfarin Under Multiple Doses Of Danicopan
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
EE/NET (0.035 mg/1 mg) was dosed as Ortho-Novum-1/35 (or generic equivalent) fixed-dose combination tablets.
Blood samples will be collected for prothrombin time/INR determination.
Time frame: Up to 168 hours postdose
Part 1: Number Of Participants With Treatment-emergent Adverse Events (TEAEs) After Multiple Doses Of Danicopan Coadministered With A Single Dose Of Warfarin
Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
Part 2: Number Of Participants With TEAEs After Multiple Doses Of Danicopan Coadministered With A Single Dose Of Bupropion
Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
Part 3: Number Of Participants With TEAEs After Multiple Doses Of Danicopan Coadministered With A Single Dose Of EE/NET
Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)