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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03709628
Other study ID # Enterome
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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