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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02103985 | A Study of Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy Participants | PHASE1 | COMPLETED | 32 | — | — | May 1, 2009 | Jun 1, 2009 | Jun 25, 2014 | 1 | United States |
The Cmax is defined as maximum observed analyte concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda\[z\]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
The Cmax is defined as maximum observed analyte concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda\[z\]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Participants will receive 100 mg JNJ-39823277 under fed (after a high fat) condition. |
| Treatment B | EXPERIMENTAL | Participants will receive 100 mg JNJ-39823277 under fasted condition. |
| Name | Type | Description |
|---|---|---|
| JNJ-39823277 | DRUG | Participants will receive 100 mg of JNJ-39823277 tablet orally (by mouth) as a single dose. |
Inclusion Criteria: * Participant must be a healthy male or non-lactating healthy female * Agrees to protocol-defined use of effective contraception * If a woman, must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and on Day -1 of each treatment period * A...