Clinical Trial Site
Tempe, Arizona, 85283, United States
NCT Number: NCT05016206
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Tempe, Arizona, 85283, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Danicopan tablets administered as a single oral dose.
Other names: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471
Moxifloxacin-matching placebo was administered as a single oral dose.
Danicopan-matching placebo was administered as a single oral dose.
Moxifloxacin 400 mg was administered as a single tablet oral dose.
Other names: Avelox
Time frame: Pre-dose through 24 hours post-dose
Time frame: Pre-dose through 24 hours post-dose
Time frame: Pre-dose through 24 hours post-dose
Time frame: Pre-dose through 24 hours post-dose
Time frame: Pre-dose through 24 hours post-dose
Time frame: Pre-dose through 24 hours post-dose
Time frame: Pre-dose through 24 hours post-dose
Time frame: Pre-dose through 24 hours post-dose
Time frame: Pre-dose through 24 hours post-dose
Time frame: Pre-dose through 24 hours post-dose
Time frame: Pre-dose through 24 hours post-dose
Time frame: Day 1 (postdose) through follow-up visit (14 [+/- 2] days after last study drug administration)]
Alexion Pharmaceuticals, Inc.
Industry
A Single Ascending Dose, Randomized, Double-Blind, Double-Dummy, Placebo- and Positive Controlled Study to Evaluate the Effect of ACH-0144471 on the QT Interval in Healthy Adult Subjects
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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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