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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02595268 | A Study to Investigate the Effect of JNJ-63623872 on Pitavastatin in Healthy Participants | PHASE1 | COMPLETED | 14 | — | — | Nov 1, 2015 | Jan 1, 2016 | Jan 27, 2016 | 1 | Belgium |
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing interval.
Cmin is the minimum observed analyte concentration.
Cmax is the maximum observed analyte concentration.
Tmax is the actual sampling time to reach the maximum observed analyte Concentration.
AUC12h is the AUC from time of administration up to 12 hours post dosing, calculated by linear-linear trapezoidal summation.
Cavg is the average steady-state plasma concentration, calculated by AUC12h / 12 hours at steady-state (12 hours = dosing interval).
Fluctuation index is percentage fluctuation (variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied by (\[Cmax - Cmin\] / Cavg).
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing interval.
Cmax is the maximum observed analyte concentration.
Tmax is the actual sampling time to reach the maximum observed analyte Concentration.
AUClast is the area under the analyte concentration vs. time curve from time 0 to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.
AUC(0-infinity) is the last observed measurable (non-BQL) concentration; extrapolations of more than 20 percent (%) of the total AUC are reported as approximations.
Lambda(z) is the apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs. time curve.
T1/2term is the apparent terminal elimination half-life, calculated as Lambda(z).
Ratio Cmax,test/ref is the ratio of individual Cmax values between test and reference Treatment. Test is Day 9 (JNJ-63623872 plus pitavastatin) and reference is Day 1(/pitavastatin alone).
Ratio AUClast,test/ref is the ratio of individual AUClast values between test and reference Treatment. Test is Day 9 (JNJ-63623872 plus pitavastatin) and reference is Day 1(/pitavastatin alone).
Ratio AUC\[infinity\],test/ref is the ratio of individual AUC\[infinity\] values between test and reference Treatment. Test is Day 9 (JNJ-63623872 plus pitavastatin) and reference is Day 1(/pitavastatin alone).
| Arm | Type | Description |
|---|---|---|
| Pitavastatin Then JNJ-63623872 | EXPERIMENTAL | Participants will sequentially receive single oral dose of pitavastatin 1 milligram (mg) on Day 1, followed by JNJ-63623872 600 mg twice daily on Days 4 through 12 with a single oral dose of pitavastatin 1 mg administered in the morning of Day 9. All study drug intakes will be taken orally, under fed conditions (within approximately 10 minutes after completion of a meal). |
| Name | Type | Description |
|---|---|---|
| Pitavastatin | DRUG | Participants will receive single oral dose of pitavastatin 1 milligram (mg) on Day 1 and Day 9. |
| JNJ-63623872 | DRUG | Participants will receive JNJ-63623872 600 mg twice daily on Days 4 through 12. |
Inclusion Criteria: * Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol * A female participant of childbearing potential must have a negative serum beta-human chorionic gonadotropin test at Screening and a negative urine pregnancy test on...