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| ID | Type | Description | Link |
|---|---|---|---|
| 63623872FLZ1014 | Other Identifier | Janssen-Cilag International NV | |
| 2018-002818-12 | EudraCT Number |
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Study 63623872FLZ1014 was terminated early based on a strategic business decision by Janssen to end the clinical development program of JNJ-63623872.
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The purpose of this study is to evaluate the pharmacokinetics (PK) of pimodivir after a single oral dose of 600 milligrams (mg) in adult participants with severe renal impairment who are not on dialysis and in adult participants with end-stage renal disease (ESRD) who are not yet on dialysis compared to adult participants with normal renal function (Part A). Optionally, to evaluate the PK in adult participants with mild and/or moderate renal impairment compared to adult participants with normal renal function (Part B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Normal renal function (control group) | Experimental | Participants with normal renal function (glomerular filtration rate [GFR] greater than or equal to [>=] 90 milliliters per minute [mL/min]) will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets. |
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| Part A: Severe renal impairment or ESRD | Experimental | Participants with severe renal impairment (GFR >=15 to less than [<]30 mL/min) who are not on dialysis or end stage renal disease (ESRD) (GFR <15 mL/min) not yet on dialysis will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets. |
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| Part B (Optional): Mild renal impairment | Experimental | Participants with mild renal impairment (GFR >=60 mL/min to <90 mL/min) will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets. |
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| Part B (Optional): Moderate renal impairment | Experimental | Participants with moderate renal impairment (GFR >=30 to <60 mL/min) will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimodivir | Drug | Participants will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed concentration (Cmax) of Pimodivir | Cmax is the maximum observed concentration. | Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6 |
| Area Under Curve From Time of Dosing to the Time of the last Measurable Concentration (AUC[0-last]) of Pimodivir | AUC(0-last) is the AUC from time of dosing to the time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation. | Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6 |
| AUC from time of dosing to infinity (AUC[0-infinity]) of Pimodivir | AUC(0-infinity) is the AUC from time of dosing to infinity, calculated as AUC(0-last) + Clast/ (lambda[z]), where Clast is the last observed measurable concentration and lambda(z) is the apparent terminal elimination rate constant. | Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to 42 (+/-) 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | 24105 | Germany | |||
| APEX GmbH |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000605010 | pimodivir |
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|
| München |
| 81241 |
| Germany |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |