Clinical trial NCT04821323: A Study Exploring the Use of Challenge Agents in Healthy Volunteers - Intervention Specific Appendix
Official title: A Phase 0 Platform Study Exploring the Use of Challenge Agents in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Longitudinal Change From Baseline in Lactulose/Mannitol Ratio in the Urine Following Indomethacin Challenge
timeFrame: Baseline, Up to 14 days
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 6 weeks
measure: Number of Participants with Treatment-Emergent Serious Adverse Events (TE-SAEs)
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Longitudinal Change From Baseline in Selected Biomarkers Following Indomethacin Challenge
timeFrame: Baseline, Up to 14 days
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: