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| ID | Type | Description | Link |
|---|---|---|---|
| 40411813EDI1011 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single dose and multiple dose administrations of JNJ-40411813 in Japanese healthy adult male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: JNJ-40411813 or Matching Placebo | Experimental | Participants will receive a single oral dose of JNJ-40411813 or a matching placebo in Cohorts 1, 2, and 3. |
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| Part 2: JNJ-40411813 | Experimental | Participants will receive a single oral dose of JNJ-40411813 in Cohort 4. |
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| Part 3: JNJ-40411813 or Matching Placebo | Experimental | Participants will receive a multiple oral dose of JNJ-40411813 or a matching placebo in Cohort 5 and optional Cohort 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-40411813 | Drug | JNJ-40411813 will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | 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 6 weeks |
| Part 3: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | 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 8 weeks |
| Parts 1 and 2: Plasma Concentration of JNJ-40411813 | Plasma samples will be analyzed to determine concentrations of JNJ-40411813 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS). | Predose, up to 96 hours postdose (Day 5) |
| Part 3: Plasma Concentration of JNJ-40411813 | Plasma samples will be analyzed to determine concentrations of JNJ-40411813 using a validated, specific, and sensitive LC-MS/MS. | Predose, up to 312 hours postdose (Day 14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Souseikai Fukuoka Mirai Hospital | Fukuoka | 813-0017 | Japan |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ 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 |
|---|---|
| C000594993 | 1-butyl-3-chloro-4-(4-phenyl-1-piperidinyl)-(1H)-pyridone |
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| Matching Placebo | Drug | Matching placebo will be administered orally. |
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