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

ConditionFamilial Adenomatous Polyposis
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • REC-4881

    Drug

    REC-4881 capsules

  • Placebo

    Drug

    Placebo capsules

Treatment groups

67 Participants
are divided into 5 treatment groups
Group A: Placebo (Part 1)Placebo comparator 1 intervention
Group B: REC-4881 4 mg (Part 1)Experimental treatment 1 intervention
Group C: REC-4881 4 mg (Part 2): QD Treatment RegimenExperimental treatment 1 intervention
Group D: REC-4881 8 mg (Part 2): QD Treatment RegimenExperimental treatment 1 intervention
Group E: REC-4881 4 mg (Part 2): Interval Dosing Treatment RegimenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Maximum (Peak) Plasma Drug Concentration (Cmax) of REC-4881

Time frame
Day 1 through Day 43
2

Part 1: Time to Reach Cmax (Tmax) of REC-4881

Time frame
Day 1 through Day 43
3

Part 1: Area Under the Plasma Concentration-time Curve (AUC) of REC-4881

Time frame
Day 1 through Day 43
4

Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
Day 1 through up to Week 37

Secondary outcomes

1

Part 1: Number of Participants With TEAEs and SAEs

Time frame
Day 1 through Day 29
2

Part 1: Number of Participants Who Discontinued Treatment

Time frame
Day 1 through Day 29
3

Part 1: Number of Participants With Dose Modification Due to Toxicity

Time frame
Day 1 through Day 29
4

Part 2: Cmax of REC-4881

Time frame
Week 1 and Week 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Recursion Pharmaceuticals Inc.

Lead sponsor

Source ClinicalTrials.gov
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