Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Recursion Pharmaceuticals Inc.
Study ID
NCT05552755
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Familial Adenomatous Polyposis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REC-4881 — DRUG
    REC-4881 capsules
  • Placebo — DRUG
    Placebo capsules

Study Details

This is a multicenter, two-part trial in participants with FAP.

Key Dates

Start date
Jul 10, 2023
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
67 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo (Part 1)
    Participants will receive a single dose of placebo administered orally and then, following 14-28 days, participants will begin once daily (QD) dosing for another 14 days.
  • Experimental: REC-4881 4 mg (Part 1)
    Participants will receive REC-4881 4 milligrams (mg) administered orally and then, following 14-28 days, participants will begin QD dosing for another 14 days.
  • Experimental: REC-4881 4 mg (Part 2): QD Treatment Regimen
    Participants will receive REC-4881 4 mg administered orally QD for 12 weeks followed by a 12 week off-treatment period.
  • Experimental: REC-4881 8 mg (Part 2): QD Treatment Regimen
    Participants will receive REC-4881 8 mg administered orally QD for 12 weeks followed by a 12 week off-treatment period.
  • Experimental: REC-4881 4 mg (Part 2): Interval Dosing Treatment Regimen
    Participants will receive REC-4881 4 mg administered orally in a 7 day on and off schedule for 24 weeks.

Primary Outcome Measure

Part 1: Maximum (Peak) Plasma Drug Concentration (Cmax) of REC-4881 [ Time Frame: Day 1 through Day 43 ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Mayo Clinic - ScottsdaleScottsdaleArizona85259-
Del Sol Research ManagementTucsonArizona85715-
Medical Associates Research GroupSan DiegoCalifornia92123-
GI ProsNaplesFlorida34102-
Digestive and Liver Center of FloridaOrlandoFlorida32825-
Gastroenterology Health Partners, PLLCNew AlbanyIndiana47150-
Tandem Clinical ResearchMarreroLouisiana70072-
Corewell Health (Spectrum Health Hospitals Colorectal Cancer Multis)Grand RapidsMichigan49503-
Mayo Clinic - RochesterRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110
Asima Badic
[email protected]
314-362-2646
Paul Wise, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Sophia Caterina
[email protected]
(215) 349-8222
Bryson Katona, MD (PRINCIPAL_INVESTIGATOR)
Gastro One-8110 Walnut RsCordovaTennessee38108-
Vanderbilt Digestive CenterNashvilleTennessee37232
Casey Koza
[email protected]
(615) 875-6642
Reid Ness, MD (PRINCIPAL_INVESTIGATOR)
Genetic Cancer Prevention Clinic - UT SouthwesternDallasTexas75390
Yamei Cheng
[email protected]
214-645-4955
Luke Engelking, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Diane Weber
[email protected]
(713) 563-5752
Eduardo Vilar-Sanchez, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute and University of UtahSalt Lake CityUtah84112
Tavia Dutson
[email protected]
(801) 646-4172
Jessica Stout, MD (PRINCIPAL_INVESTIGATOR)
Benaroya Research Institute at Virginia MasonSeattleWashington98101
Brooke Grubb
[email protected]
(206) 287-6260
Emily Chesterfield
[email protected]
Gautam Mankaney, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic - Scottsdale· Scottsdale, AZDel Sol Research Management· Tucson, AZMedical Associates Research Group· San Diego, CAGI Pros· Naples, FLDigestive and Liver Center of Florida· Orlando, FLGastroenterology Health Partners, PLLC· New Albany, IN

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