This was a randomized, double-blind, double-dummy, placebo- and positive-controlled, 2-arm (Treatment Arm and Control Arm), parallel study to evaluate the effect of ACH-0144471 (danicopan) on the QT interval in healthy adult participants.
Participants randomized to the Treatment Arm received all 3 doses of danicopan in a single ascending fashion over 3 periods (Treatment Sequence ABC). A single oral dose of danicopan was administered with a moxifloxacin-matching placebo on Day 1 of each period. Participants randomized to the Control Arm were further randomized to receive 1 of 2 treatment sequences (Treatment Sequences EFG or IJK). A single oral dose of danicopan-matching placebo was administered with moxifloxacin or with moxifloxacin-matching placebo, as per the assigned randomization scheme, on Day 1 of each period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
33
Danicopan tablets administered as a single oral dose.
Moxifloxacin-matching placebo was administered as a single oral dose.
Danicopan-matching placebo was administered as a single oral dose.
Clinical Trial Site
Tempe, Arizona, United States
Placebo-corrected Change From Baseline In QTc Intervals (ddQTc) For Danicopan
Time frame: Pre-dose through 24 hours post-dose
Change From Baseline In Heart Rate (HR) For Danicopan
Time frame: Pre-dose through 24 hours post-dose
Change From Baseline In QT Interval For Danicopan
Time frame: Pre-dose through 24 hours post-dose
Change From Baseline In Pulse Rate (PR) For Danicopan
Time frame: Pre-dose through 24 hours post-dose
Change From Baseline In RR Interval For Danicopan
Time frame: Pre-dose through 24 hours post-dose
Change From Baseline In QRS Interval For Danicopan
Time frame: Pre-dose through 24 hours post-dose
ddQTcF Of Moxifloxacin
Time frame: Pre-dose through 24 hours post-dose
Treatment-emergent T-wave Morphology Abnormalities And Pathologic U-waves
Time frame: Pre-dose through 24 hours post-dose
Area Under The Plasma Concentration Versus Time Curve From Time 0 To 24 Hours Post-dose (AUC0-24) Of Danicopan
Time frame: Pre-dose through 24 hours post-dose
Maximum Observed Plasma Concentration (Cmax) Of Danicopan
Time frame: Pre-dose through 24 hours post-dose
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Moxifloxacin 400 mg was administered as a single tablet oral dose.
Time To Reach The Maximum Observed Plasma Concentration (Tmax) Of Danicopan
Time frame: Pre-dose through 24 hours post-dose
Number Of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 (postdose) through follow-up visit (14 [+/- 2] days after last study drug administration)]