Evaluating REC-4881 for Familial Adenomatous Polyposis (FAP)
This study is testing REC-4881 capsules in people with Familial Adenomatous Polyposis (FAP), a genetic condition that causes growths (polyps) in the colon and rectum. The study aims to understand how REC-4881 works in the body (pharmacokinetics), its safety, and how well it treats FAP. You may be able to join if you are 18 or older, have a diagnosis of FAP affecting your duodenum or remaining colon/rectum/pouch, and have had surgery to remove part or all of your colon. The study will measure how much REC-4881 is in your blood over about six weeks to understand its effects. The current status of this study is unclear.
- Study design
- This is a two-part study involving 67 participants. It is an interventional study, meaning participants will receive either REC-4881 or a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measurements for REC-4881 in the body are taken from Day 1 through Day 43.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)
At a glance
Conditions
NCT05552755
Where you'd take part
This study runs at 17 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Benaroya Research Institute at Virginia Mason
Seattle, Washingtonstudy coordinator listed
Recruiting
Genetic Cancer Prevention Clinic - UT Southwestern
Dallas, Texasstudy coordinator listed
Recruiting
Huntsman Cancer Institute and University of Utah
Salt Lake City, Utahstudy coordinator listed
Recruiting
MD Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Vanderbilt Digestive Center
Nashville, Tennesseestudy coordinator listed
Recruiting
Washington University School of Medicine
St Louis, Missouristudy coordinator listed
Recruiting
Corewell Health (Spectrum Health Hospitals Colorectal Cancer Multis)
Grand Rapids, Michiganno site contact published
Active, not recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Part 1: Maximum (Peak) Plasma Drug Concentration (Cmax) of REC-4881Day 1 through Day 43
- Part 1: Time to Reach Cmax (Tmax) of REC-4881Day 1 through Day 43
- Part 1: Area Under the Plasma Concentration-time Curve (AUC) of REC-4881Day 1 through Day 43
- Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Day 1 through up to Week 37
- Part 2: Number of Participants With Dose-limiting Toxicities (DLTs)First 28 days of treatment
- Part 2: Number of Participants Who Discontinued TreatmentDay 1 through up to Week 37
- Part 2: Number of Participants With Dose Modification Due to ToxicityDay 1 through up to Week 37
- Part 2: Percent Change From Baseline in Polyp BurdenBaseline, up to Week 37