Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-27 @ 12:17 AM
Study NCT ID:
NCT05763459
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy Subjects
Sponsor:
Calico Life Sciences LLC
Organization:
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Drug-Drug Interaction Between ABBV-CLS-7262, Rosuvastatin, and Digoxin Following Multiple Doses of ABBV-CLS-7262
Status:
COMPLETED
Status Verified Date:
2023-06
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 study follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262
Detailed Description:
Period 1: One single dose of rosuvastatin and one single dose of digoxin on Day 1.
Period 2: Multiple doses of ABBV-CLS-7262 once daily from Day 1 to Day 8. On Day 5, one single dose of rosuvastatin and one single dose of digoxin with the dose of ABBV-CLS-7262 on that day.
Period 2: Multiple doses of ABBV-CLS-7262 once daily from Day 1 to Day 8. On Day 5, one single dose of rosuvastatin and one single dose of digoxin with the dose of ABBV-CLS-7262 on that day.
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?: