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| ID | Type | Description | Link |
|---|---|---|---|
| 67953964EDI1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2019-001864-31 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-67953964 | Drug | Participants will receive JNJ-67953964 as oral capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
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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| ID | Term |
|---|---|
| C000590915 | Aticaprant |
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| Placebo | Drug | Participants will receive matching placebo oral capsules. |
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| 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. | 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. | 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. | 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. | 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. | Up to 15 Weeks |