Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-39823277 · 1 trial · 1 indication
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...
JNJ-39823277 is an investigational small molecule being studied in healthy participants. It is not intended for a specific disease indication, as the clinical trial focuses on healthy volunteers to assess the drug's pharmacokinetics, particularly the effect of food on a single dose. It is in Phase 1 clinical development.
JNJ-39823277 is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical research on this investigational small molecule in healthy participants.
JNJ-39823277 is in Phase 1 clinical development. The single completed trial was a Phase 1 study in healthy participants. It is an investigational drug and has not been approved by regulatory authorities, as it is still in early-stage clinical research.
JNJ-39823277 has one completed clinical trial, identified as NCT02103985. This Phase 1 study, titled "A Study of Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy Participants," enrolled 32 healthy adults in the United States and evaluated how food affects the drug's pharmacokinetics.
Yes, JNJ-39823277 is also known as TPI-1062. The clinical trial NCT02103985 references both names, indicating they refer to the same investigational small molecule being studied in healthy participants.