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

April 25, 2025 updated by: Janssen Research & Development, LLC

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Merksem, Belgium, 2170
        • Clinical Pharmacology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1: JNJ-67953964 or Placebo
Participants will receive JNJ-67953964 or matching placebo oral capsules once daily (QD) over 4 weeks (28 days).
Drug: Placebo
Participants will receive matching placebo oral capsules.
Drug: JNJ-67953964
Participants will receive JNJ-67953964 as oral capsules.
Other Names:
  • Cerecor (CERC)-501
Experimental: Cohort 2: JNJ-67953964 or Placebo
Participants in this cohort will receive JNJ-67953964 only or will be randomly assigned to receive JNJ-67953964 or matching placebo.
Drug: Placebo
Participants will receive matching placebo oral capsules.
Drug: JNJ-67953964
Participants will receive JNJ-67953964 as oral capsules.
Other Names:
  • Cerecor (CERC)-501

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Microscopic Signs of Parietal Cell Damage
Time Frame: Day 28
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Microscopic Signs of Ulcers or Erosions in the Gastric Biopsies
Time Frame: Day 28
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.
Day 28
Percentage of Participants with a Gastroscopy Lanza Score Greater than or Equal to (>=) 2
Time Frame: Day 28
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.
Day 28
Percentage of Participants with a Gastroscopy Lanza Score Equal to (=) 4
Time Frame: Day 28
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.
Day 28
Distribution of all Gastroscopy Lanza Scores
Time Frame: Day 28
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.
Day 28
Gastric pH Before and up to 4 Hours After Dosing
Time Frame: Day 1: Predose up to 4 hours postdose
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.
Day 1: Predose up to 4 hours postdose
Percentage of Participants with Adverse Events (AEs) and AEs Related to Upper Gastrointestinal Symptoms
Time Frame: Up to 15 Weeks
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.
Up to 15 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108686
  • 67953964EDI1001 (Other Identifier: Janssen Research & Development, LLC)
  • 2019-001864-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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