Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 67953964EDI1002 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single- and multiple-dose oral administration of JNJ-67953964 in healthy Japanese adult male participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose Cohort: Cohort 1 and 2 | Experimental | Participants will receive a single oral dose of JNJ-67953964 or a matching placebo on Day 1. |
|
| Multiple Dose Cohort: Cohort 3 | Experimental | Participants will receive multiple oral dose of JNJ-67953964 once daily or a matching placebo up to Day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-67953964 | Drug | JNJ-67953964 capsule will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) for Single- dose Cohort | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 5 weeks |
| Number of Participants with AEs for Multiple- dose Cohort | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 7 weeks |
| Plasma Concentration of JNJ-67953964 for Single- dose Cohort | Plasma samples will be analyzed to determine concentrations of JNJ-67953964 using a fully validated liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) method. | Up to Day 5 |
| Plasma Concentration of JNJ-67953964 for Multiple- dose Cohort | Plasma samples will be analyzed to determine concentrations of JNJ-67953964 using a fully validated LC-MS/MS method. | Up to Day 17 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumida Hospital | Tokyo | 130-0004 | Japan |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000590915 | Aticaprant |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo will be administered orally. |
|