Clinical trial NCT04185051: A Study to Investigate the Effect of JNJ-67953964 on Gastric Mucosal Integrity in Healthy Male and Female Participants
Official title: A Double-blind, Randomized, Placebo Controlled, 4-week Study to Investigate the Effect of JNJ-67953964 on Gastric Mucosal Integrity in Healthy Male and Female Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main purpose of the study is to investigate the upper gastro-intestinal (GI)-related safety and tolerability in healthy participants by gastroscopy and gastric biopsies after treatment with 25 milligram (mg) JNJ-67953964 once daily (QD) over 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 30 kilograms per meter square (kg/m\^2). Minimum body weight should be 50 kilogram (kg)
* 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
* Non-smokers (not smoked for 3 months prior to screening)
* A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose
* A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person until 90 days after receiving the last dose of study intervention

Exclusion Criteria:

* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* History of any gastric surgery, documented gastric disease (including peptic ulcer disease, gastritis, achlorhydria, upper gastro-intestinal (GI) bleeding, esophagitis, or any GI precancerous condition), current clinically evident GI complaints including functional gastrointestinal disorders (FGID)
* Is positive for helicobacter (H.) pylori antigen in a stool test at screening
* Is diagnosed to have any gastric disease (macroscopic) as visually assessed by gastroscopy at screening
* History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening

Primary outcomes:
measure: Percentage of Participants with Microscopic Signs of Parietal Cell Damage
timeFrame: Day 28
Secondary outcomes:
measure: Percentage of Participants with Microscopic Signs of Ulcers or Erosions in the Gastric Biopsies
timeFrame: Day 28
measure: Percentage of Participants with a Gastroscopy Lanza Score Greater than or Equal to (>=) 2
timeFrame: Day 28
measure: Percentage of Participants with a Gastroscopy Lanza Score Equal to (=) 4
timeFrame: Day 28
measure: Distribution of all Gastroscopy Lanza Scores
timeFrame: Day 28
measure: Gastric pH Before and up to 4 Hours After Dosing
timeFrame: Day 1: Predose up to 4 hours postdose
measure: Percentage of Participants with Adverse Events (AEs) and AEs Related to Upper Gastrointestinal Symptoms
timeFrame: Up to 15 Weeks
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: