Clinical Trial: Evaluate REC-4881 in Patients With FAP

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: A Phase 2, Multicenter, Trial to Evaluate Efficacy, Safety, and Pharmacokinetics, and Pharmacodynamics of REC-4881 in Patients With Familial Adenomatous Polyposis (FAP)

Brief Summary: This is a multicenter, two-part trial in participants with Familial Adenomatous Polyposis (FAP).

Detailed Summary: This is a Phase 2, trial to evaluate efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of REC-4881 in participants with FAP.
This two-part study is designed to characterize the safety, tolerability, PK, PD, and preliminary activity of REC-4881 administered orally (PO) at multiple doses on a once daily schedule in participants with phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
Sponsor: Recursion Pharmaceuticals Inc.

Current Primary Outcome: Maximum (peak) plasma drug concentration (Cmax), time to reach maximum (peak) plasma concentration (Tmax), and area under the plasma concentration-time curve (AUC)

Original Primary Outcome: Maximum (peak) plasma drug concentration (Cmax), time to reach maximum (peak) plasma concentration (Tmax), and area under the plasma concentration-time curve (AUC)

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Recursion Pharmaceuticals Inc.

Dates:
Date Received: September 14, 2022
Date Started: July 10, 2023
Date Completion: July 10, 2023
Last Updated: November 02, 2023
Last Verified: November 01, 2023