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

NCT04185051 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR10868667953964EDI10012019-001864-31
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 28

Secondary Outcomes (6)

• Percentage of Participants with Microscopic Signs of Ulcers or Erosions in the Gastric Biopsies

  Day 28

• Percentage of Participants with a Gastroscopy Lanza Score Greater than or Equal to (>=) 2

  Day 28

• Percentage of Participants with a Gastroscopy Lanza Score Equal to (=) 4

  Day 28

• Distribution of all Gastroscopy Lanza Scores

  Day 28

• Gastric pH Before and up to 4 Hours After Dosing

  Day 1: Predose up to 4 hours postdose

Study Arms (2)

Cohort 1: JNJ-67953964 or Placebo

EXPERIMENTAL

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

Drug: JNJ-67953964; Drug: Placebo

Cohort 2: JNJ-67953964 or Placebo

EXPERIMENTAL

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

Drug: JNJ-67953964; Drug: Placebo

Interventions

JNJ-67953964 DRUG

Participants will receive JNJ-67953964 as oral capsules.

Also known as: Cerecor (CERC)-501

Cohort 1: JNJ-67953964 or Placebo; Cohort 2: JNJ-67953964 or Placebo

Placebo DRUG

Participants will receive matching placebo oral capsules.

Cohort 1: JNJ-67953964 or Placebo; Cohort 2: JNJ-67953964 or Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

Aticaprant

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: December 17, 2019
• Primary Completion: April 21, 2021
• Study Completion: May 5, 2021
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)