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NCT04560816 · ClinicalTrials.gov registry record · Phase 1
A Study of the Cardiac Effects of ALXN1840 in Healthy Adults
A Phase 1 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT04560816: Completed Phase 1 study, sponsored by Alexion Pharmaceuticals.
NCT04560816 is a Phase 1 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04560816, a Phase 1 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
This study will evaluate the effect of a supratherapeutic dose of ALXN1840 on the heart rate (HR)-corrected QT interval (QTc) in healthy adult participants. Moxifloxacin will be used as the active control.
Primary Outcome
Twelve-lead electrocardiograms (ECGs) were extracted from approximately 25-hour continuous (Holter) recordings on Day -1 of Treatment Period 1 and Days 1 and 2 in each treatment period. Change from baseline in the QT interval was corrected for heart rate using Fridericia's formula (ΔQTcF). ΔQTcF was based on a mixed-effects model for repeated measures (MMRM) with ΔQTcF as the dependent variable; period, sequence, time, treatment, and time-by-treatment interaction as fixed effects; and baseline Q
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG ALXN1840
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2020-07-24 |
| Est. Completion | 2021-03-24 |
| Phase | Phase 1 |
What the finished NCT04560816 record still lists
NCT04560816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04560816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04560816 about?
NCT04560816 is a clinical study titled "A Study of the Cardiac Effects of ALXN1840 in Healthy Adults". This study will evaluate the effect of a supratherapeutic dose of ALXN1840 on the heart rate (HR)-corrected QT interval (QTc) in healthy adult participants. Moxifloxacin will be used as the active control.
What is the current status of trial NCT04560816?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2020-07-24. Estimated completion is 2021-03-24.
What interventions are being tested in trial NCT04560816?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), ALXN1840 (DRUG).
Who is sponsoring clinical trial NCT04560816?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04560816's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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