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Completed

NCT Number: NCT03709628

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

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical University Vienna, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EB8018 (First-in-class FimH blocker)

Drug

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 names: EB8018

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Enterome

Industry

Registry information

Official study title

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

Acronym: EBFIM117

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2018
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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