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

NCT ID: NCT04821323

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2021-05-07

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Indomethacin Challenge

Participants will receive challenge agent as two single oral doses of Indomethacin, one on Day -1 and one on Day 1. In addition, participants will receive lactulose-mannitol solution on Day -4 (baseline) and on Day 1 (post Indomethacin challenge).

Group Type: EXPERIMENTAL

Indomethacin

Intervention Type: DRUG

Indomethacin capsules will be administered orally.

Lactulose-mannitol

Intervention Type: DIAGNOSTIC_TEST

Lactulose-mannitol solution will be administered orally.

Interventions

Indomethacin

Indomethacin capsules will be administered orally.

Intervention Type: DRUG

Lactulose-mannitol

Lactulose-mannitol solution will be administered orally.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• healthy on the basis of physical examination, medical history, and vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
• healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
• must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (example, nicotine patch) for 3 months prior to screening
• A woman must be: a) not of childbearing potential; b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of less than (<1) percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until the end of the intervention cohort. The investigator should evaluate the potential for contraceptive method failure (example, noncompliance, recently initiated) in relationship to the first dose of study intervention
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test prior to study intervention administration on Day -4

Exclusion Criteria

• history of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• history of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia. These include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenia and chronic granulomatous disease
• has an active, acute or chronic infection
• has a history of inflammatory bowel disease (IBD), celiac disease, or gastrointestinal diseases (GI) surgery, excluding appendectomy and cholecystectomy
• has known allergies, hypersensitivity, or intolerance to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

NOPRODPCNAP0001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108965

Identifier Type: -

Identifier Source: org_study_id