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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
76
Participants will receive JNJ-67953964 as oral capsules.
Participants will receive matching placebo oral capsules.
Clinical Pharmacology Unit
Merksem, Belgium
Percentage of Participants with Microscopic Signs of Parietal Cell Damage
Microscopic signs of parietal cell damage is defined as the any of the following observations to be present in at least 2 biopsy specimens collected during a gastroscopy session: greater than (\>) 25 percent (%) decrease in the number of parietal cells from baseline in the gastric biopsies at visit 4 or multifocal to diffuse parietal cell apoptosis or degeneration.
Time frame: Day 28
Percentage of Participants with Microscopic Signs of Ulcers or Erosions in the Gastric Biopsies
Microscopic signs of ulcers or erosions in the gastric biopsies will be assessed by high resolution gastroscopy using the 5-point Lanza scale: 0 = normal stomach, 1= mucosal hemorrhages only, 2 = 1 or 2 erosions, 3 = numerous (3-10) areas of erosion, and 4 = large number of erosions (\>10) or ulcer.
Time frame: Day 28
Percentage of Participants with a Gastroscopy Lanza Score Greater than or Equal to (>=) 2
Gastroscopy lanza scale is a 5-point scale where: 0 = normal stomach, 1= mucosal hemorrhages only, 2 = 1 or 2 erosions, 3 = numerous (3-10) areas of erosion, and 4 = large number of erosions (\>10) or ulcer.
Time frame: Day 28
Percentage of Participants with a Gastroscopy Lanza Score Equal to (=) 4
Gastroscopy lanza scale is a 5-point scale where: 0 = normal stomach, 1= mucosal hemorrhages only, 2 = 1 or 2 erosions, 3 = numerous (3-10) areas of erosion, and 4 = large number of erosions (\>10) or ulcer.
Time frame: Day 28
Distribution of all Gastroscopy Lanza Scores
Gastroscopy lanza scale is a 5-point scale where: 0 = normal stomach, 1= mucosal hemorrhages only, 2 = 1 or 2 erosions, 3 = numerous (3-10) areas of erosion, and 4 = large number of erosions (\>10) or ulcer.
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Time frame: Day 28
Gastric pH Before and up to 4 Hours After Dosing
Gastric pH before and up to 4 hours after dosing will be measured. To measure gastric pH a nasal-gastric tube will be placed about one hour before dosing and remain in place until 4 hours after dosing.
Time frame: Day 1: Predose up to 4 hours postdose
Percentage of Participants with Adverse Events (AEs) and AEs Related to Upper Gastrointestinal Symptoms
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Time frame: Up to 15 Weeks