A Study to Investigate the Effect of JNJ-67953964 on Gastric Mucosal Integrity in Healthy Male and Female Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: JNJ-67953964

Study type: Interventional

Funder types: Industry

Identifiers

NCT04185051

2019-001864-31 (EudraCT Number)

CR108686

67953964EDI1001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Cohort 1: JNJ-67953964 or Placebo

Experimental group

Description:

Participants will receive JNJ-67953964 or matching placebo oral capsules once daily (QD) over 4 weeks (28 days).

Treatment:

Drug: JNJ-67953964

Drug: Placebo

Cohort 2: JNJ-67953964 or Placebo

Experimental group

Description:

Participants in this cohort will receive JNJ-67953964 only or will be randomly assigned to receive JNJ-67953964 or matching placebo.

Treatment:

Drug: JNJ-67953964

Drug: Placebo