Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03189498 | A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function | PHASE1 | COMPLETED | 38 | — | — | Jul 11, 2017 | Dec 6, 2017 | Feb 3, 2025 | 2 | Germany |
The Cmax is the maximum observed plasma concentration.
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration.
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
| Arm | Type | Description |
|---|---|---|
| Group 1: Participants With Normal Renal Function | EXPERIMENTAL | Adult participants with normal renal function (estimated glomerular filtration rate \[eGFR\] greater than or equal to \[\>=\] 90 milliliter per minute \[mL/min\]) will receive a single oral dose of 1,000 milligram (mg) JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period. |
| Group 2: Participants With Mild Renal Impairment | EXPERIMENTAL | Adult participants with mild impaired renal function (eGFR \>=60 to less than \[\<\] 90 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period. |
| Group 3: Participants With Moderate Renal Impairment | EXPERIMENTAL | Adult participants with moderate impaired renal function (eGFR \>=30 to \<60 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period. |
| Group 4: Participants With Severe Renal Impairment | EXPERIMENTAL | Adult participants with severe impaired renal function (eGFR \>= 15 to \<30 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period. |
| Group 5: Participants With ESRD With or Without Hemodialysis | EXPERIMENTAL | Adult participants with end-stage renal disease (ESRD) (eGFR \<15 mL/min if not on hemodialysis or requiring hemodialysis treatment for at least 3 months before screening if on hemodialysis) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period. Participants with ESRD on hemodialysis will be dosed on an interdialysis day within 24 hours of their last hemodialysis treatment. |
| Name | Type | Description |
|---|---|---|
| JNJ-64041575 | DRUG | All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250 mg tablets) on Day 1. |
Inclusion Criteria: * Participant must have a body mass index (BMI: body weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 36.0 kilogram per meter square (kg/m\^2), extremes included, and a body weight not less than 50.0 kg, inclusive, at screening * Contraceptive use by...