Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05552755
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2022-09-14
Brief Title:
Evaluate REC-4881 in Patients With FAP
Sponsor:
Recursion Pharmaceuticals Inc
Organization:
Recursion Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1b-2 Multicenter Trial To Evaluate The Efficacy Safety Pharmacokintetics And Pharmacodynamics Of REC-4881 in Patients With Familial Adenomatous Polyposis FAP
Status:
RECRUITING
Status Verified Date:
2024-08
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:
TUPELO
Brief Summary:
This is a multicenter two-part trial in participants with Familial Adenomatous Polyposis FAP
Detailed Description:
This is a Phase 1b2 trial to evaluate efficacy safety pharmacokinetics and pharmacodynamics of REC-4881 in participants with Familial Adenomatous Polyposis FAP This two-part study will treat participants with phenotypic classical FAP with disease involvement of the duodenum or the residual colonrectumpouch as the primary disease site
Part 1 of the study enrolled seven participants with FAP who are post-colectomyproctocolectomy Participants were randomized to Placebo or REC-4881
Part 2 of the study will treat participants with escalating dose levels of REC-4881 during the Dose Finding Participates in Cohort Expansion will be treated with a doses to determine the RP2D
Part 1 of the study enrolled seven participants with FAP who are post-colectomyproctocolectomy Participants were randomized to Placebo or REC-4881
Part 2 of the study will treat participants with escalating dose levels of REC-4881 during the Dose Finding Participates in Cohort Expansion will be treated with a doses to determine the RP2D
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