Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591845
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Thorough QTQTc TQT Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Center Randomized Partially Double-Blind Placebo- and Active-Controlled Four-period Crossover Thorough QTQTc TQT Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center randomized partially double-blind placebo and active-controlled 4-period crossover design thorough QTQTc TQT clinical study to evaluate the effects of ziresovir on cardiac repolarization in healthy subjects
Detailed Description:
This clinical study is a single-center randomized partially double-blind placebo- and active-controlled four-period crossover design with healthy subjects comprising the enrolled population Ziresovir and placebo will be administered in a double-blind manner while moxifloxacin hydrochloride tablets will be administered in as open-label
Thirty-two subjects meeting all inclusion criteria and none of the exclusion criteria will be randomized into 1 of 12 dosing sequences each consisting of 4 periods with an 8-day washout period in-between
Thirty-two subjects meeting all inclusion criteria and none of the exclusion criteria will be randomized into 1 of 12 dosing sequences each consisting of 4 periods with an 8-day washout period in-between
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None