Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310876
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-03-04
Brief Title:
A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects
Sponsor:
Calico Life Sciences LLC
Organization:
Calico Life Sciences LLC
Study Overview
Official Title:
A Phase 1 Placebo-and Active-Controlled Crossover Study of the Potential for Cardiac Repolarization Effects Following Single Dose of ABBV-CLS-7262 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-06
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 is a randomized blinded placebo and active-controlled 4-period crossover design thorough QTQTc TQT study to evaluate the effect of ABBV-CLS-7262 on cardiac repolarization in healthy adult subjects
Detailed Description:
This is a randomized blinded placebo and active-controlled 4-period crossover study The study will be double-blinded for ABBV-CLS-7262 dose 1 or dose 2 and placebo regimens and open-label for moxifloxacin 72 subjects are planned to be enrolled
All subjects will receive a single oral dose of 4 different study treatments over 4 separate treatment periods each separated by a washout period
On Day 1 of each period subjects will receive either ABBV-CLS-7262 dose 1 ABBV-CLS-7262 dose 2 placebo or moxifloxacin 400 mg
In each period cardiodynamic ECGs will be collected pre-dose and for 24 hours post-dose and PK blood samples will be collected pre-dose and for 48 hours post-dose Safety will be monitored throughout the study by repeated clinical and laboratory evaluations
All subjects will receive a single oral dose of 4 different study treatments over 4 separate treatment periods each separated by a washout period
On Day 1 of each period subjects will receive either ABBV-CLS-7262 dose 1 ABBV-CLS-7262 dose 2 placebo or moxifloxacin 400 mg
In each period cardiodynamic ECGs will be collected pre-dose and for 24 hours post-dose and PK blood samples will be collected pre-dose and for 48 hours post-dose Safety will be monitored throughout the study by repeated clinical and laboratory evaluations
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