Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04560816
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2020-09-18
Brief Title:
A Study of the Cardiac Effects of ALXN1840 in Healthy Adults
Sponsor:
Alexion Pharmaceuticals Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized 3-Treatment 3-Period 6-Sequence Crossover Placebo- and Active-Controlled Double-Blind for ALXN1840 Open-Label for Moxifloxacin Thorough QTQTc Study to Evaluate ALXN1840 on Cardiac Repolarization in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This is a randomized 3-treatment 3-period 6-sequence crossover placebo- and active-controlled double-blind for ALXN1840 open-label for moxifloxacin in healthy adult participants Participants will be domiciled in the clinic for 7 days during Treatment Period 1 and for 6 days during Treatment Period 2 and 3 A single oral dose of each treatment ALXN1840 matching ALXN1840 placebo or moxifloxacin will be administered on Day 1 of each period following an overnight fast of at least 10 hours There will be a minimum 14-day washout between study intervention administrations for each treatment period Cardiodynamic pharmacokinetic and safety assessments will be performed at certain times during the study An end-of-study visit will occur 14 days 2 days after the last dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None