HealthyPhase 1NCT04185051
A Study to Investigate the Effect of JNJ-67953964 on Gastric Mucosal Integrity in Healthy Male and Female Participants
A Phase 1 study testing JNJ-67953964 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-67953964
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Dec 2019to 5 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- JNJ-67953964, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-67953964Drug
Also called Cerecor (CERC)-501
Participants will receive JNJ-67953964 as oral capsules.
PlaceboDrug
Participants will receive matching placebo oral capsules.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: JNJ-67953964; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 15 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start17 Dec 2019
- Primary completion21 Apr 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185051
- Sponsor's protocol ID
- CR108686
- Other IDs
- 67953964EDI1001, 2019-001864-31, 2019
- Status last verified
- Apr 2025
- First submitted
- 2 Dec 2019
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04185051
- Acronym / sponsor ID
- CR108686
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: JNJ-67953964 or Placebo | Experimental | Drug: JNJ-67953964, Drug: PlaceboParticipants will receive JNJ-67953964 or matching placebo oral capsules once daily (QD) over 4 weeks (28 days). |
| Cohort 2: JNJ-67953964 or Placebo | Experimental | Drug: JNJ-67953964, Drug: PlaceboParticipants in this cohort will receive JNJ-67953964 only or will be randomly assigned to receive JNJ-67953964 or matching placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-67953964Also: Cerecor (CERC)-501Participants will receive JNJ-67953964 as oral capsules. | Drug | Cohort 1: JNJ-67953964 or Placebo, Cohort 2: JNJ-67953964 or Placebo |
| PlaceboParticipants will receive matching placebo oral capsules. | Drug | Cohort 1: JNJ-67953964 or Placebo, Cohort 2: JNJ-67953964 or Placebo |
Primary outcome
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.
6 secondary outcomes
Percentage of Participants with Microscopic Signs of Ulcers or Erosions in the Gastric Biopsies
Time frame: Day 28
Percentage of Participants with a Gastroscopy Lanza Score Greater than or Equal to (>=) 2
Time frame: Day 28
Percentage of Participants with a Gastroscopy Lanza Score Equal to (=) 4
Time frame: Day 28
Distribution of all Gastroscopy Lanza Scores
Time frame: Day 28
Gastric pH Before and up to 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
Time frame: Up to 15 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-67953964 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Microscopic Signs of Parietal Cell Damage (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.