Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06145607
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2023-11-17
Brief Title:
A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262
Sponsor:
Calico Life Sciences LLC
Organization:
Calico Life Sciences LLC
Study Overview
Official Title:
A Phase 1 Study to Evaluate Safety Tolerability and Food-Effect Following Administration of ABBV-CLS-7262 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-03
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 is a randomized three period six sequence single dose crossover design with ABBV-CLS-7262 in healthy adult subjects
Detailed Description:
On Day 1 of each period subjects will receive a single oral dose of ABBV-CLS-7262 administered according to the food regimen assigned There will be a 4-day washout period between doses Food regimens include administration after fasting following a high-fathigh-calorie meal or with apple sauce Upon completion each subject will have taken a total of three doses of ABBV-CLS-7262 with one dose administered with each food regimen
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