Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05387759
Status:
COMPLETED
Last Update Posted:
2023-10-12
First Post:
2022-05-20
Brief Title:
A Thorough QT Study of Aticaprant JNJ-67953964 in Healthy Adult Participants
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Randomized Double-blind Placebo- and Positive-controlled Single-dose 4-way Crossover Study to Evaluate the Effects of Aticaprant JNJ-67953964 on Electrocardiogram Intervals in Healthy Adult Participants
Status:
COMPLETED
Status Verified Date:
2023-10
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:
The purpose of this study is to assess the effects of aticaprant on QT QT interval corrected for heart rate HR QTc intervals and electrocardiogram ECG morphology at therapeutic and supratherapeutic exposures in healthy adult participants
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 67953964MDD1001 | OTHER | Janssen Research Development LLC | None |
| 2021-002618-15 | EUDRACT_NUMBER | None | None |