Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411860
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-29
Brief Title:
A Study to Assess the Effect of Olpasiran on QTQTc Intervals in Healthy Participants
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Randomized Placebo- and Positive-controlled Crossover Study to Assess the Effect of Olpasiran AMG 890 on QTQTc Intervals in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-10
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 primary objective of the study is
To assess the effects of a single therapeutic and supratherapeutic dose of olpasiran on the placebo-corrected change from baseline in QT corrected for heart rate ΔΔQTQTc interval in healthy participants
To assess the effects of a single therapeutic and supratherapeutic dose of olpasiran on the placebo-corrected change from baseline in QT corrected for heart rate ΔΔQTQTc interval in healthy 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?:
None
Is an FDA AA801 Violation?:
None