Clinical Trial Site
Tempe, Arizona, 85283, United States
NCT Number: NCT04660890
This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 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 will receive ALXN2050 in a multiple-ascending doses fashion over 3 periods (treatment sequence ABC). Participants randomized to the control arms will be further randomized to 1 of 2 treatment sequences (treatment sequence DEF or GHI) to receive placebo or active control over 3 periods.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ALXN2050 will be administered orally twice daily as powder-in-capsule.
Other names: ACH-0145228 (formerly)
ALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule.
Moxifloxacin will be administered as a single oral dose.
Moxifloxacin-matching placebo will be administered as a single oral dose.
Time frame: Pre-dose through 24 hours post-dose
Twelve-lead electrocardiograms (ECGs) will be extracted from continuous (Holter) recordings.
Time frame: Pre-dose through 24 hours post-dose
Twelve-lead ECGs will be extracted from continuous (Holter) recordings.
Time frame: Pre-dose through 24 hours post-dose
Twelve-lead ECGs will be extracted from continuous (Holter) recordings.
Time frame: Pre-dose through 24 hours post-dose
Time frame: Up to 24 hours postdose
Time frame: Pre-dose through 24 hours post-dose
Time frame: Day 1 (postdose) through follow-up (7 [+/- 2] days after last study drug administration)
Alexion Pharmaceuticals, Inc.
Industry
A Multiple-Ascending-Dose, Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled Study to Evaluate the Effect of ALXN2050 on the QT Interval in Healthy Adult Participants
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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