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A Study Exploring the Use of Challenge Agents in Healthy Volunteers - Intervention Specific Appendix

NCT04821323 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-06-25

No results posted yet for this study

Summary

The purpose of this study is to characterize the disruption of intestinal barrier as a result of indomethacin challenge in healthy volunteers using an orally administered lactulose-mannitol test.

Conditions

  • Healthy

Interventions

DRUG

Indomethacin

Indomethacin capsules will be administered orally.

DIAGNOSTIC_TEST

Lactulose-mannitol

Lactulose-mannitol solution will be administered orally.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2021-05-07
Completion
2021-05-07

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821323 on ClinicalTrials.gov