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| ID | Type | Description | Link |
|---|---|---|---|
| 64565111OBE1003 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of study is to evaluate the pharmacokinetics of a single, subcutaneous dose of JNJ-64565111 in adult participants with varying degrees of renal function including participants with end stage renal disease, requiring hemodialysis, compared with participants with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: JNJ-64565111 | Experimental | Participants with normal renal function and no evidence of kidney damage (estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 90 milliliter/minute [mL/min]) will be enrolled. Participants will receive a single subcutaneous (SC) dose of JNJ-64565111 on Day 1. |
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| Group 2: JNJ-64565111 | Experimental | Participants with mild renal impairment (eGFR 60 to less than [<] 90 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
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| Group 3: JNJ-64565111 | Experimental | Participants with moderate renal impairment (eGFR 30 to <60 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
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| Group 4: JNJ-64565111 | Experimental | Participants with severe renal impairment (eGFR <30 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
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| Group 5: JNJ-64565111 | Experimental | Participants with end-stage renal disease (requiring hemodialysis 3 times per week for at least 3 months before screening; eGFR will not be calculated) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64565111 | Drug | All participants will receive a single SC dose of JNJ-64565111 solution on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Analyte Concentration (Cmax) of JNJ-64565111 | Cmax is the maximum observed serum analyte concentration of JNJ-64565111. | Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose |
| Area Under the Serum Analyte Concentration-Time Curve from Time Zero to Last Measurable (not Below Quantification Limit) Concentration (AUC[0-last]) of JNJ-64565111 | AUC [0-Last] is the area under the serum analyte concentration versus time curve from time zero to the time of the last measurable (not below quantification limit) concentration of JNJ-64565111, calculated by linear-linear trapezoidal summation. | Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose |
| Area Under the Serum Analyte Concentration-Time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64565111 | AUC (0-infinity) is the area under the serum analyte concentration-time curve from time zero to infinite time, calculated as AUC(last) + C(last)/lamda(z) where C(last) is the last observed measurable (not below quantification limit) concentration of JNJ-64565111. | Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Antibodies to JNJ-64565111 | Number of participants with antibodies to JNJ-64565111 will be reported. | Predose, Days 7, 29 and 42 |
| Number of Participants with Adverse Events |
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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 Clinical Research Center | Orlando | Florida | 32809 | United States | ||
| AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.
| Approximately 9 weeks |
| Knoxville |
| Tennessee |
| 37923 |
| United States |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |