A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients

Crohn Disease Clinical Trial

— EBFIM117  

Official title:

An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709628
• Other study ID #: Enterome
• Status: Completed
• Phase: Phase 1
• Start date: March 7, 2018
• Est. completion date: December 4, 2019

Study information

• Verified date: February 2021
• Source: Enterome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Enterome small molecule drug EB8018 is a first-in-class FimH blocker to be studied in Crohn's disease patients. The proposed indication for EB8018, as an add-on therapy, will be the treatment of adult patients suffering from Crohn's disease.

Description:

This open-label, multicenter study will enroll 8 evaluable patients with active Crohn's disease and will consist of 2 parts. Part 1 will include 2 sentinel patients with a single dosing period followed by a 13-day multiple dosing period. Part 2 will include the 6 remaining patients with multiple dosing only. This Phase 1b study will investigate the PK, safety, preliminary effects of the gut microbiome, and inflammatory biomarkers of EB8018 following 13 days of consecutive BID oral dosing in patients with Crohn's disease. Part 1 of this study will demonstrate a single oral dose of EB8018 that is safe and tolerable in patients with Crohn's disease and Part 2 of this study will characterize the PK profile when administered as multiple oral doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 4, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Selection Criteria:

• Male and female patients of nonchildbearing potential =18 years of age at screening and Day -1
• Active Crohn's disease based on an elevated calprotectin at baseline.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• EB8018 (First-in-class FimH blocker)
Drug: EB8018 EB8018 is an orally administered, first-in-class, FimH blocker • In Part 1, a single oral dose of EB8018 3000 mg will be administered to the 2 sentinel patients in the morning on Day 1. In the multi-dose treatment period (part 1 and 2), multiple oral doses of EB8018 1500 mg will be administered to 2 + 6 patients BID (in the morning and evening) on Days 1 through 13.

Locations

Country	Name	City	State
Austria	Medical University Vienna	Wien
France	Hôpital Claude Huriez	Lille
France	Hôpital de l'Archet 2	Nice
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel
Italy	Istituto Clinico Humanitas	Rozzano

Sponsors (1)

Lead Sponsor	Collaborator
Enterome

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut Microbiome	Overall gene richness and relative abundance of Bacteroidetes, Enterobacteriaceae, and Firmicutes from sequencing of stool samples.	Up to Day22
Other	Inflammatory Biomarkers	C-reactive protein	Up to Day22
Other	Inflammatory Biomarkers	Fecal calprotectin	Up to Day22
Other	CDAI score	CDAI calculation will be dependent on the parameters recorded in the subjects' diary and the parameters assessed at clinic visit by the investigator.	Up to Day22
Primary	Cmax	Maximum observed plasma concentration	Day1, Day13
Primary	Tmax	Time to maximum observed plasma concentration	Day1
Primary	AUC0-24	Area under the plasma concentration time curve from time 0 to 24 hours	Day1; Day13
Primary	T1/2	Terminal elimination half-life	Day1; Day13
Secondary	AE	Adverse events	Up to Day22
Secondary	RR	Inter-Beat intervalle (sec)	Up to Day22
Secondary	QRS complex	intervalle (sec)	Up to Day22
Secondary	QT	duration (sec)	Up to Day22
Secondary	PR	intervalle (sec)	Up to Day22
Secondary	HR	Heart rate (bpm)	Up to Day22
Secondary	BP	Blood pressure (mmHg)	Up to Day22
Secondary	RR	Respiratory rate (breaths per minute)	Up to Day22
Secondary	Temp	Temperature (C°)	Up to Day22