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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02049697 | A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants | PHASE1 | COMPLETED | 6 | — | — | Apr 1, 2009 | May 1, 2009 | Jan 30, 2014 | 1 | Belgium |
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.
T1/2 is the time measured for the plasma concentration to decrease by one-half of 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 |
|---|---|---|
| 14C-JNJ-39823277 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 14C-JNJ-39823277 | DRUG | Participants will receive a single oral dose of 25 mg 14C-JNJ-39823277 as a 50-mL solution. |
Inclusion Criteria: * Body mass index (BMI) between 20 and 30 kg/m2 (BMI will be calculated as weight \[kg\]/square of height \[square meter\]) * Had consistent bowel movement habit (approximately once per day) within 30 days before dosing * No clinically significant laboratory and electrocardiogra...