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| ID | Type | Description | Link |
|---|---|---|---|
| 39439335 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of a single dose of 3 capsule formulations of JNJ-39439335 in healthy adult male volunteers. The effect of food on the pharmacokinetics of one of the capsule formulations of JNJ-39439335 will also be evaluated during the study.
This is an open-label (the name of the study drug will be known to the healthy volunteers participating in this study as well as to all study staff), randomized (volunteers will be assigned by chance to 1 of 6 possible treatment sequences of a single dose of 3 different capsule formulations of JNJ-39439335) to evaluate the pharmacokinetics (blood levels of drug) and relative bioavailability (i.e., the rate and extent of absorption of the drug in the body) of JNJ-39439335 (Part 1 of the study). The effect of food on the administration of JNJ-39439335 will then be evaluated on 1 capsule formulation of JNJ-39439335 (Part 2 of the study). The safety and tolerability of JNJ-39439335 will be monitored throughout Part 1 and 2 of the study. In Part 1, healthy volunteers will be randomly assigned to 1 of 6 treatment sequences and will receive a total of 3 single doses of JNJ-39439335. Each dose (2 capsules) will be separated by 21 days. In Part 2, healthy volunteers will be randomly assigned to 1 of 2 treatment sequences and will receive a total of 2 single doses of one formulation selected from Part 1; each dose will be separated by 21 days. Doses will be administered to healthy volunteers under fed and fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | JNJ-39439335 Part 1:Type=1 unit=mg number=25 form=capsule route=oral use. One capsule (25 mg/day) taken once on Day 1 in 3 treatment periods. or Part 1:Type=2 unit=mg number=12.5 form=capsule route=oral use. Two capsules (25 mg/day) taken once on Day 1 in 3 treatment periods.,JNJ-39439335 Part 2:Type=2 unit=mg number=12.5 form=capsule route=oral use. Two capsules taken (25 mg/day) once on Day 1 in 2 treatment periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-39439335 | Drug | Part 2:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules taken (25 mg/day) once on Day 1 in 2 treatment periods. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters (Area Under the Curve [AUC]) of JNJ-39439335 | Up to approximately 70 days (14 days after each of 3 doses of study drug in Part I of the study and after each of 2 doses in Part 2 of the study. | |
| Maximum plasma concentration [Cmax]) of JNJ-39439335 | Up to approximately 70 days |
| Measure | Description | Time Frame |
|---|---|---|
| No secondary outcome measures are reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC C. Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overland Park | Kansas | United States |
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| JNJ-39439335 | Drug | Part 1:Type=1, unit=mg, number=25, form=capsule, route=oral use. One capsule (25 mg/day) taken once on Day 1 in 3 treatment periods. or Part 1:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules (25 mg/day) taken once on Day 1 in 3 treatment periods. |
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