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

Early Phase 1

Completed

• Conditions: Crohn Disease
• Interventions: Drug: MB-102; Drug: Lactulose/Rhamnose solution

• Registration Number: NCT03962998
• Lead Sponsor: MediBeacon

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).

Detailed Description

This study is a single center, randomized, open label, cross-over study evaluating MB-102 versus dual sugar testing using lactulose and rhamnose for the assessment of gut permeability. Participants will be screened within 30 days of Day 1, and eligible participants will be randomized to receive either an oral dose of MB-102 or the dual sugar test on Day 1. At a second study visit occurring between 3 to 7 days after completion of the first test, participants will return to the study center for the second test. Following completion of the second test, participants will return to the study center 7 ±3 days for a follow-up visit to evaluate safety.

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-24
• Study Start: 2019-10-27
• Primary Completion: 2021-10-05
• Study Completion: 2021-10-05
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MB-102	MB-102	4 μmol of MB-102/kg body weight administered orally as a solution
Lactulose/Rhamnose	Lactulose/Rhamnose solution	1000 mg of lactulose and 200 mg of rhamnose administered orally as a 10 mL solution

Primary Outcome Measures

Name	Time	Method
Mean urine concentration of MB-102 over time in normal participants and in those with Crohn's disease	Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours	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.

Secondary Outcome Measures

Name	Time	Method
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	For MB-102 excretion evaluation, 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. For the dual sugar test, participants will consume a 10 mL solution (1000 mg of lactulose and 200 mg of rhamnose). Urine will be collected pre-dose (time 0), each time the participant voids, and at the protocol-defined time points after consuming the sugar solution. The total volume of urine excreted will be recorded. Urine samples will be analyzed using validated analytical methods.

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States