Ignite Creation Date:
2024-05-06 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03471130
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2018-02-28
Brief Title:
Definitive QT Study With MT-8554
Sponsor:
Mitsubishi Tanabe Pharma America Inc
Organization:
Mitsubishi Tanabe Pharma America Inc
Study Overview
Official Title:
A Phase I Randomised Double-blind Placebo-controlled Parallel-group Study to Evaluate the Effect of MT-8554 at Two Dose Levels MT-8554 Low Dose and MT-8554 High Dose on the QTQTc Interval in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2023-05
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:
MT-8554 DQT
Brief Summary:
This is a study to definitively assess the effects of MT 8554 adjusted for placebo on the change of the QT interval corrected for heart rate HR using the Fridericia formula QTcF from Baseline in healthy adult subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004138-27 | EUDRACT_NUMBER | None | None |