A Phase 1b-2, Multicenter, Trial to Evaluate the Efficacy, Safety, Pharmacokintetics, and Pharmacodynamics of REC-4881 in Patients With Familial Adenomatous Polyposis (FAP)
Recursion Pharmaceuticals Inc.
Summary
This is a multicenter, two-part trial in participants with FAP.
Description
This is a Phase 1b/2 trial to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of REC-4881 in participants with FAP. This two-part study will treat participants with phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female and ≥ 18 years of age 2. Have provided written informed consent to participate in the study 3. Diagnosis of phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site. 4. Genetic diagnosis of FAP with APC gene mutation (Part 2 only). 5. Has undergone colectomy or subtotal colectomy 6. Spigelman Classification Stage II or higher. 7. Investigator/Participant agrees to leave polyps ≤10 mm unresected during endoscopies performed at Screening and while on study 8. Have no significant cardiov…
Interventions
- DrugREC-4881
REC-4881 capsules
- DrugPlacebo
Placebo capsules
Locations (17)
- Mayo Clinic - ScottsdaleScottsdale, Arizona
- Del Sol Research ManagementTucson, Arizona
- Medical Associates Research GroupSan Diego, California
- GI ProsNaples, Florida
- Digestive and Liver Center of FloridaOrlando, Florida
- Gastroenterology Health Partners, PLLCNew Albany, Indiana