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| ID | Type | Description | Link |
|---|---|---|---|
| 41443532EDI1002 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
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The purpose of this study is to assess the safety, tolerability pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and how it is removed from the body over time) and pharmacodynamics (the effects of the drug) of JNJ-41443532 in healthy male and female Caucasian and male Japanese participants.
This is a randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled, parallel group, single dose study in male and female Caucasian and male Japanese participants. The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) study in healthy male and female caucasian and male Japanese participants. For each participant, the study will consist of a screening examination (within 28 days of first dose on Day 1), a single period of open label treatment (all people involved know the identity of the intervention) upon entry in the study and discharge on Day 3), and a final, follow-up examination between 7-10 days after discharge from the study. Safety assessments include monitoring of adverse events, and evaluation of lab results, cardiac parameters, vital signs, and physical exams. Participants receive study medication (JNJ-41443532 or placebo) by mouth on Day 1 after an overnight fast of at least 10 hours; planned dose is 250 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | JNJ-41443532 250mg tablet once daily for 1 day |
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| 002 | Placebo Comparator | Placebo Matching placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo |
| |
| JNJ-41443532 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the pharmacokinetic properties of a single dose JNJ-41443532 as determined by blood level concentrations. | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the pharmacodynamic (PD) effects of JNJ-41443532 and to compare differences in the PD profile by age, sex, and race. | 6 Weeks | |
| To explore the relationship between JNJ-41443532 plasma concentrations (blood levels) and pharmacodynamic effects (concentration-effect relationships). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cypress | California | United States |
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| ID | Term |
|---|---|
| C000599181 | JNJ-41443532 |
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| Drug |
250mg tablet once daily for 1 day |
|
| 6 Weeks |
| Determine the safety and tolerability of JNJ-41443532 as determined by evaluation of adverse events, lab results, cardiac monitoring, vital signs, and physical exams. | 6 Weeks |