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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRecursion Pharmaceuticals Inc.

About this trial

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

Eligibility criteria

Qualifiers

Male or female and ≥ 18 years of age

Have provided written informed consent to participate in the study

Diagnosis of phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.

Genetic diagnosis of FAP with APC gene mutation (Part 2 only).

Disqualifiers

Has any clinically significant laboratory abnormality, medical or psychiatric illness which, in the opinion of the Investigator, could interfere with the conduct or interpretation of the study or put the participant at risk.

Has had prior pelvic irradiation.

Has gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881, including difficulty swallowing capsules.

Has received treatment with other investigational agents within the 4 weeks prior to Study Day 1 or a period during which the investigational agent has not been cleared from the body (that is, at least a period of 5 half-lives, if known), whichever is longer.

Trial design

Treatments tested in this trial

  • REC-4881
  • Placebo

Treatment groups

67 Participants
are divided into 5 treatment groups

Sponsors and collaborators