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| ID | Type | Description | Link |
|---|---|---|---|
| 38518168ARA1005 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to characterize the pharmacokinetics (what the body does to the study medication) of JNJ-38518168 at approximately steady-state (stable medication levels) after administration of multiple oral 30 mg doses of JNJ-38518168 to participants with mild or moderate hepatic (liver) impairment (abnormal function) compared with participants with normal hepatic function.
This is an open-label (both [participants and investigator] know what treatment participants will receive) and multicenter study. The study consists of 3 phases: a screening phase (approximately 3 weeks), a treatment phase (from day -2 [2 days before the administration of study medication] to Day 18), and an end-of-study phase (7 to 10 days after the last dose of study medication). Approximately 24 participants (participants with mild hepatic impairment, moderate hepatic impairment, and normal liver function) will receive JNJ-38518168 for 14 days. Hepatic impairment will be evaluated according to Child-Pugh score. It consists of 5 clinical measures (amount of ascites [an abnormal accumulation of fluid in the abdomen], total bilirubin [mg/dL], albumin [g/dL], international normalized ratio, and degree of encephalopathy [abnormal functioning of the brain]). Each is scored from 0 (less severity) to 3 (highest severity). Total Child-Pugh score is the sum of all subscores and is graded as: mild (5-6 points), moderate (7-9 points), and severe (10-15 points). Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, vital signs, body weight, physical examination, and 12-lead electrocardiogram which will be monitored at various timepoints throughout the study. The total duration of study participation for each participant is approximately 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-38518168 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-38518168 | Drug | All participants will receive JNJ-38518168 30 mg tablet once daily from Day 1 to Day 14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of JNJ-38518168 at approximately steady-state after multiple doses | Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours]) | |
| Area under the plasma concentration-time curve of JNJ-38518168 at approximately steady-state after multiple doses | Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours]) | |
| Time to reach the maximum observed plasma of JNJ-38518168 at approximately steady-state after multiple doses | Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours]) | |
| Apparent clearance of JNJ-38518168 at approximately steady-state after multiple doses | Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours]) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of JNJ-38518168 after single dose | Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours]) | |
| Area under the plasma concentration-time curve of JNJ-38518168 after single dose | Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours]) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando | Florida | United States | ||||
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| Time to reach the maximum observed plasma of JNJ-38518168 after single dose | Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours]) |
| Urine concentration-time data of JNJ-38518168 after single dose | Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours]) |
| Plasma protein binding of JNJ-38518168 | Day 1 (postdose [4 hours]) and Day 14 (predose, postdose [4 hours]) |
| Number of participants with adverse events | Up to 6 weeks |
| Knoxville |
| Tennessee |
| United States |
| San Antonio | Texas | United States |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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