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| ID | Type | Description | Link |
|---|---|---|---|
| 41443532EDI1001 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
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The purpose of this study is to investigate the safety, tolerability, food effect as well as the 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 single and multiple ascending doses of JNJ-41443532 in healthy male 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, single and multiple ascending dose study conducted at a single study center. The study has 4 parts. Part 1 is a randomized, double-blind, alternating panel, single ascending oral dose study. Two alternating treatment panels (A and B) each with nine healthy male participants will be studied with successively increasing dose levels. Part 2 is a randomized, open-label (all people involved know the identity of the intervention), 2-period crossover study to evaluate what the effect of administering JNJ- 41443532 with food (i.e. standard high fat breakfast meal) relative to administration in the fasted state will have on pharmacokinetics/blood levels of JNJ-41443532. Part 3 is a randomized, double-blind, single oral dose study in obese, otherwise healthy male participants. Part 4 is a double-blind, randomized, placebo-controlled multiple ascending dose study in up to 5 sequential treatment groups of healthy male participants. Safety assessments include monitoring of adverse events, and evaluation of lab results, cardiac parameters, vital signs, and physical exams. In Parts 1, 2, and 3 participants receive study medication (JNJ-41443532 or placebo) orally on Day 1 after an overnight fast of at least 10 hours; planned doses are 25 to 1500 mg. In Part 4, participants receive study medication (JNJ-41443532 or placebo) orally each day for 10 consecutive days after an overnight fast of at least 10 hours; planned doses are 100 to 1000 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | JNJ-41443532 25mg tablet once daily |
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| 002 | Experimental | JNJ-41443532 100mg tablet once daily |
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| 003 | Experimental | JNJ-41443532 250mg tablet once daily |
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| 004 | Experimental | JNJ-41443532 500mg once daily (with 250mg tablets) |
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| 005 | Experimental | JNJ-41443532 1000mg once daily (with 250mg tablets) |
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| 006 | Experimental | JNJ-41443532 1500mg once daily (with 250mg tablets) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-41443532 | Drug | 25mg tablet once daily |
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| JNJ-41443532 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the pharmacokinetic properties of single and multiple doses JNJ-41443532 as determined by blood level concentrations. | Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety and tolerability of JNJ-41443532 as determined by evaluation of adverse events, lab results, cardiac monitoring, vital signs, and physical exams. | Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks | |
| To explore the relationship between JNJ-41443532 plasma concentrations 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 |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| 007 |
| Placebo Comparator |
Placebo Matching placebo |
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| Drug |
250mg tablet once daily |
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| JNJ-41443532 | Drug | 1500mg once daily (with 250mg tablets) |
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| JNJ-41443532 | Drug | 100mg tablet once daily |
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| JNJ-41443532 | Drug | 1000mg once daily (with 250mg tablets) |
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| Placebo | Drug | Matching placebo |
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| JNJ-41443532 | Drug | 500mg once daily (with 250mg tablets) |
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| Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks |
| To explore the pharmacodynamic (PD) effects of JNJ-41443532 and to compare the differences between treatment groups | Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks |
| ID | Term |
|---|---|
| C000599181 | JNJ-41443532 |
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