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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-17

Study Completion Date

2021-05-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PPI and Microbiome in Healthy Volunteers and Functional Dyspepsia

NCT03545243

Dysbiosis

COMPLETED PHASE4

To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects

NCT03291418

Gastric Ulcer

COMPLETED PHASE1/PHASE2

A Study of Baricitinib and Omeprazole in Healthy Participants

NCT01925144

Healthy Volunteers

COMPLETED PHASE1

A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

NCT03561090

Gastroesophageal Reflux Disease (GERD)

TERMINATED PHASE3

Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

NCT03561883

Gastroesophageal Reflux Disease (GERD)

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1: JNJ-67953964 or Placebo

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

Group Type EXPERIMENTAL

JNJ-67953964

Intervention Type DRUG

Participants will receive JNJ-67953964 as oral capsules.

Placebo

Intervention Type DRUG

Participants will receive matching placebo oral capsules.

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.

Group Type EXPERIMENTAL

JNJ-67953964

Intervention Type DRUG

Participants will receive JNJ-67953964 as oral capsules.

Placebo

Intervention Type DRUG

Participants will receive matching placebo oral capsules.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

JNJ-67953964

Participants will receive JNJ-67953964 as oral capsules.

Intervention Type DRUG

Placebo

Participants will receive matching placebo oral capsules.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cerecor (CERC)-501

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes