A Phase 1b-2, Multicenter, Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of REC-4881 in Patients with Familial Adenomatous Polyposis (FAP)

Conditions

Familial Adenomatous Polyposis

Brief summary

Part 1: Plasma PK parameters as appropriate, including but not limited to maximum (peak) plasma drug concentration (Cmax), time to reach maximum (peak) plasma concentration following drug administration (Tmax), and area under the plasma concentration-time curve (AUC)., Part 2: •Treatment emergent adverse events and DLTs •Serious adverse events •Treatment discontinuation and dose modification due to toxicity •Percent change from baseline in polyp burden after 12 weeks, 25 weeks, and 37 weeks (Interval Dosing regimen only) and EoT

Detailed description

Part 1: •Treatment emergent adverse events •Serious adverse events •Treatment discontinuation and dose modification due to toxicity, Part2: •PK parameters including but not limited to: Cmax, Tmax, trough plasma concentrations (Ctrough), and AUCtau Change from baseline in: •Polyp number •Polyp number >5 mm •Highest histological grade •Spigelman Stage Classification for duodenal polyposis •InSiGHT Stage for rectal/pouch polyposis

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Interventions

DRUGREC-4881

DRUGThe placebo is formulated from inactive components of the REC-4881 4 mg capsules include: mannitol

DRUGmicrocrystalline cellulose

DRUGhydroxypropyl cellulose

DRUGcroscarmellose sodium

DRUGand magnesium stearate.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: Plasma PK parameters as appropriate, including but not limited to maximum (peak) plasma drug concentration (Cmax), time to reach maximum (peak) plasma concentration following drug administration (Tmax), and area under the plasma concentration-time curve (AUC)., Part 2: •Treatment emergent adverse events and DLTs •Serious adverse events •Treatment discontinuation and dose modification due to toxicity •Percent change from baseline in polyp burden after 12 weeks, 25 weeks, and 37 weeks (Interval Dosing regimen only) and EoT	—

Measure

Time frame

Part 1: Plasma PK parameters as appropriate, including but not limited to maximum (peak) plasma drug concentration (Cmax), time to reach maximum (peak) plasma concentration following drug administration (Tmax), and area under the plasma concentration-time curve (AUC)., Part 2: •Treatment emergent adverse events and DLTs •Serious adverse events •Treatment discontinuation and dose modification due to toxicity •Percent change from baseline in polyp burden after 12 weeks, 25 weeks, and 37 weeks (Interval Dosing regimen only) and EoT

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Secondary

Measure	Time frame
Part 1: •Treatment emergent adverse events •Serious adverse events •Treatment discontinuation and dose modification due to toxicity, Part2: •PK parameters including but not limited to: Cmax, Tmax, trough plasma concentrations (Ctrough), and AUCtau Change from baseline in: •Polyp number •Polyp number >5 mm •Highest histological grade •Spigelman Stage Classification for duodenal polyposis •InSiGHT Stage for rectal/pouch polyposis	—