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A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients (EBFIM117)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709628
Recruitment Status : Active, not recruiting
First Posted : October 17, 2018
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Enterome

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: EB8018 (First-in-class FimH blocker) Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter, open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Patients with active Crohn's disease
EB8018: 3000 mg for the single dose in Part 1 (2 sentinel patients) and 1500 mg BID for multiple dose administration over 13 days in Parts 1 and 2 (2 sentinel patients and 6 remaining patients), oral.
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.

Other Name: EB8018




Primary Outcome Measures :
  1. Cmax [ Time Frame: Day1, Day13 ]
    Maximum observed plasma concentration

  2. Tmax [ Time Frame: Day1 ]
    Time to maximum observed plasma concentration

  3. AUC0-24 [ Time Frame: Day1; Day13 ]
    Area under the plasma concentration time curve from time 0 to 24 hours

  4. T1/2 [ Time Frame: Day1; Day13 ]
    Terminal elimination half-life


Secondary Outcome Measures :
  1. AE [ Time Frame: Up to Day22 ]
    Adverse events

  2. RR [ Time Frame: Up to Day22 ]
    Inter-Beat intervalle (sec)

  3. QRS complex [ Time Frame: Up to Day22 ]
    intervalle (sec)

  4. QT [ Time Frame: Up to Day22 ]
    duration (sec)

  5. PR [ Time Frame: Up to Day22 ]
    intervalle (sec)

  6. HR [ Time Frame: Up to Day22 ]
    Heart rate (bpm)

  7. BP [ Time Frame: Up to Day22 ]
    Blood pressure (mmHg)

  8. RR [ Time Frame: Up to Day22 ]
    Respiratory rate (breaths per minute)

  9. Temp [ Time Frame: Up to Day22 ]
    Temperature (C°)


Other Outcome Measures:
  1. Gut Microbiome [ Time Frame: Up to Day22 ]
    Overall gene richness and relative abundance of Bacteroidetes, Enterobacteriaceae, and Firmicutes from sequencing of stool samples.

  2. Inflammatory Biomarkers [ Time Frame: Up to Day22 ]
    C-reactive protein

  3. Inflammatory Biomarkers [ Time Frame: Up to Day22 ]
    Fecal calprotectin

  4. CDAI score [ Time Frame: Up to Day22 ]
    CDAI calculation will be dependent on the parameters recorded in the subjects' diary and the parameters assessed at clinic visit by the investigator.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709628


Locations
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Austria
Medical University Vienna
Wien, Austria
France
Hôpital Claude Huriez
Lille, France
Hôpital de l'Archet 2
Nice, France
Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany
Italy
Istituto Clinico Humanitas
Rozzano, Italy
Sponsors and Collaborators
Enterome

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Responsible Party: Enterome
ClinicalTrials.gov Identifier: NCT03709628    
Other Study ID Numbers: Enterome
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases