Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability

NCT03962998 | Completed Early Phase 1 FDA Drug

• 1 other identifier: MB-300-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the study are to evaluate the safety and tolerability of oral administration of MB-102, and to evaluate the use of MB-102 as a means of measuring gut permeability in normal participants (n=10) and in those with radiologic evidence of small bowel Crohn's disease (n=10).

Conditions

Crohn Disease

Keywords

Gut permeability; Intestinal permeability; MB-102

Outcome Measures

Primary Outcomes (1)

• Mean urine concentration of MB-102 over time in normal participants and in those with Crohn's disease

  Urine samples will be collected pre-dose (time 0), each time the participant voids, and at the protocol-defined time points after oral administration of MB-102. The total volume of urine excreted will be recorded. Urine samples will be analyzed using validated analytical methods.

  Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours

Secondary Outcomes (1)

• Correlation between MB-102 excretion and the results of dual sugar testing in normal participants and in those with Crohn's disease

  Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours

Study Arms (2)

Lactulose/Rhamnose

ACTIVE COMPARATOR

1000 mg of lactulose and 200 mg of rhamnose administered orally as a 10 mL solution

Drug: Lactulose/Rhamnose solution

MB-102

EXPERIMENTAL

4 μmol of MB-102/kg body weight administered orally as a solution

Drug: MB-102

Interventions

Lactulose/Rhamnose solution DRUG

Lactulose/Rhamnose solution administered orally followed by measurement of excreted lactulose and rhamnose in urine

Lactulose/Rhamnose

MB-102 DRUG

MB-102 solution administered orally followed by measurement of excreted MB-102 in urine

MB-102

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years - male or non-pregnant or lactating females
• Participants willing to comply with study requirements
• Participants who have signed an informed consent form
• Normal or non-clinically significant screening and baseline 12 lead electrocardiogram (ECG) in the opinion of the principal investigator (PI)
• Estimated glomerulofiltration rate (eGFR) \> 75 mL/min/1.73 m\^2
• Agreement to not utilize nonsteroidal anti-inflammatory drugs (NSAIDs) until study completion.
• Participants with active small bowel Crohn's disease diagnosed by an abnormal Magnetic Resonance Enterography (MRE) within 1 month prior to screening
• Active Crohn's disease must be characterized by mucosal hyperemia, and/or bowel wall thickening and/or vascular engorgement

You may not qualify if:

• Women who are pregnant, lactating, or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use an adequate method of birth control a. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose
• Participation in another interventional trial within 30 days of dosing or concurrently enrolled in any other medical research study which could impact the results of the study
• Unable to tolerate an overnight fast
• NSAID use within 14 days of Day 1
• History of drug or alcohol abuse within the past year
• Diagnosis of ulcerative colitis, indeterminate colitis, pseudomembranous colitis, or celiac disease
• Prior or current diagnosis of an autoimmune disease
• Gastrointestinal surgery (including appendectomy) within 12 weeks prior to screening or has surgery planned or deemed likely to require surgery during the study
• Type 1 or 2 diabetes
• History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, or MB-102 (intolerance to a drug is not considered a drug allergy)
• Known history of testing positive for acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
• Site personnel immediately associated with the study or their immediate family members
• Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
• Prior exposure to MB-102
• Any changes to chronic medication therapy or initiation of new medications between Testing Day 1 and Testing Day 2

Sponsors & Collaborators

• MediBeacon: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Lactulose; relmapirazin

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Richard B Dorshow, PhD

  MediBeacon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 24, 2019
• Study Start: October 27, 2019
• Primary Completion: October 5, 2021
• Study Completion: October 5, 2021
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)