Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-64041575 · 3 trials · 2 indications
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.
Cmax is the maximum observed plasma concentration.
Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \[non BQL\]) concentration, calculated by linear trapezoidal summation.
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 (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Cmax is the maximum observed plasma concentration.
Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \[non BQL\]) concentration, calculated by linear trapezoidal summation.
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 (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-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. |
| Treatment sequence AB | EXPERIMENTAL | Participants will receive Treatment A (1000 milligram (mg) oral dose of JNJ-64041575 on Day 1) in Period 1, followed by Treatment B (1000 mg oral dose of JNJ-64041575 on Day 22 along with probenecid 500 mg on Day 21 to Day 28) in Period 2. A washout Period of 21 days will be maintained between each Period. |
| Treatment sequence BA | EXPERIMENTAL | Participants will receive Treatment B (1000 mg oral dose of JNJ-64041575 on Day 1 along with probenecid 500 mg on Day -1 to Day 7) in Period 1, followed by Treatment A (1000 mg oral dose of JNJ-64041575 on Day 22) in Period 2. A washout Period of 21 days will be maintained between each Period. |
| Panel 1: Treatment ABC | EXPERIMENTAL | Participants will receive 240 milligram (mg) JNJ-64041575 as 6.0 milliliter (mL) of a 40-milligram per milliliter (mg/mL) current oral suspension formulation (reference 1) under fasted conditions (Treatment A) in period 1, then 4.0 mL of a 60-mg/mL new concept oral suspension formulation (test 1) under fasted conditions (Treatment B) in period 2 followed by 4.0 mL of a 60-mg/mL new concept oral suspension formulation (test 2) under fed conditions (Treatment C) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| Panel 1: Treatment BCA | EXPERIMENTAL | Participants will receive Treatment B (test 1) in period 1, then Treatment C (test 2) in period 2 followed by Treatment A (reference 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| Panel 1: Treatment CAB | EXPERIMENTAL | Participants will receive Treatment C (test 2) in period 1, then Treatment A (reference 1) in period 2 followed by Treatment B (test 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| Panel 1: Treatment ACB | EXPERIMENTAL | Participants will receive Treatment A (reference 1) in period 1, then Treatment C (test 2) in period 2 followed by Treatment B (test 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| Panel 1: Treatment BAC | EXPERIMENTAL | Participants will receive Treatment B (test 1) in period 1, then Treatment A (reference 1) in period 2 followed by Treatment C (test 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| Panel 1: Treatment CBA | EXPERIMENTAL | Participants will receive Treatment C (test 2) in period 1, then Treatment B (test 1) in period 2 followed by Treatment A (reference 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| Panel 2: Treatment DEF | EXPERIMENTAL | Participants will receive JNJ-64041575 as 1 tablet of the 250-mg current oral tablet formulation (reference 2) under fasted conditions (Treatment D) in period 1, then 1 tablet of the 250-mg new concept oral tablet formulation (test 3) under fasted conditions (Treatment E) in period 2 followed by 1 tablet of the 250-mg new concept oral tablet formulation (test 4) under fed conditions (Treatment F) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| Panel 2: Treatment EFD | EXPERIMENTAL | Participants will receive Treatment E (test 3) in period 1, then Treatment F (test 4) in period 2 followed by Treatment D (reference 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| Panel 2: Treatment FDE | EXPERIMENTAL | Participants will receive Treatment F (test 4) in period 1, then Treatment D (reference 2) in period 2 followed by Treatment E (test 3) then in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| Panel 2: Treatment DFE | EXPERIMENTAL | Participants will receive Treatment D (reference 2) in period 1, then Treatment F (test 4) in period 2 followed by Treatment E (test 3) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| Panel 2: Treatment EDF | EXPERIMENTAL | Participants will receive Treatment E (test 3) in period 1, then Treatment D (reference 2) in period 2 followed by Treatment F (test 4) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| Panel 2: Treatment FED | EXPERIMENTAL | Participants will receive Treatment F (test 4) in period 1, then Treatment E (test 3) in period 2 followed by Treatment D (reference 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods. |
| 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. |
| Probenecid | DRUG | One 500-mg tablet administered as a single oral dose with a total of 30 doses (2 doses on Day -1/21 starting in the evening followed by 4 doses per day on the rest of the days). |
| JNJ-64041575 (oral suspension formulation) | DRUG | Participants will receive 240 mg JNJ-64041575 under fasted and fed conditions in Panel 1 as current/new concept oral suspension formulation. |
| JNJ-64041575 (oral tablet formulation ) | DRUG | Participants will receive 250 mg JNJ-64041575 under fasted and fed conditions in Panel 2 as current/new concept oral tablet formulation. |
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...
JNJ-64041575 is an investigational small molecule being studied in healthy volunteers and in adults with renal insufficiency. Clinical trials have evaluated its pharmacokinetics, including how different formulations are absorbed and how renal impairment affects drug levels. It is not approved and remains in Phase 1 clinical development.
JNJ-64041575 is being developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company has sponsored Phase 1 clinical trials of the drug in healthy participants and in those with renal impairment.
JNJ-64041575 is in Phase 1 clinical development. All three completed trials were early-stage studies focused on pharmacokinetics, formulation comparisons, food effects, and the impact of renal function. The drug is investigational and has not been approved by regulatory authorities.
JNJ-64041575 has been studied in three completed Phase 1 trials: NCT03010059 assessed relative bioavailability of new formulations and food effects in 48 healthy adults in Belgium; NCT03105986 evaluated the effect of probenecid on pharmacokinetics in 18 healthy adults in Germany; NCT03189498 examined renal impairment effects in 38 adults in Germany.
JNJ-64041575 is the sole name used for this drug in clinical trial records. No alternative names or aliases have been associated with it in the available data. All three trials reference the same compound name consistently.