Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-49122944, 5 milligram · 1 trial · 1 indication
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
The Cmax is the maximum observed plasma concentration during dosing interval.
The AUC(last) is the area under the plasma concentration time curve from time 0 to the time corresponding to the last quantifiable plasma 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.
Percentage of area under the plasma concentration-time curve obtained by extrapolation (%AUC\[inf,ex\]) is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100 (AUC\[0-infinity\] - AUC\[0-last\])\*100/AUC\[0-infinity\].
Elimination half-life (t \[1/2\]) is associated with the terminal slope (lambda \[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Apparent clearance of JNJ-49122944 is calculated as Dose/AUC(infinity). The AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time.
Apparent volume of distribution after intravenous administration is calculated as Dose divided by Lambda(z) multiplied by AUC(0-inifinity).
| Arm | Type | Description |
|---|---|---|
| JNJ-49122944, 5 milligram (mg) | EXPERIMENTAL | Single dose of 5 mg JNJ-49122944, administered as a 22.2 milliliter (mL) intravenous (IV) infusion over 45 minutes in the morning following an overnight fast. |
| Placebo | PLACEBO_COMPARATOR | Placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes in the morning following an overnight fast. |
| Name | Type | Description |
|---|---|---|
| JNJ-49122944, 5 milligram (mg) | DRUG | Participants will receive single dose of 5 mg JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1. |
| Placebo | DRUG | Participants will receive placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1. |
Inclusion Criteria: * Male participant, aged 18 to 55 inclusive * Participant must have a body Mass Index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2), inclusive, and body weight not less than 50 kg * Participant must be deemed healthy on the basis of physical examination, medical hi...
JNJ-49122944, 5 milligram is a small molecule drug candidate developed by Johnson & Johnson (ticker: JNJ). It is an investigational agent that has been studied in a Phase 1 clinical trial. The 5 milligram designation refers to a specific dose strength of the compound.
JNJ-49122944, 5 milligram is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ. Johnson & Johnson is the sponsor of the clinical trial evaluating this drug candidate.
JNJ-49122944, 5 milligram is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently approved by the FDA. As an investigational drug, it remains in the early stages of clinical testing.
JNJ-49122944, 5 milligram has been evaluated in a single Phase 1 clinical trial, NCT02280018. This completed study assessed the safety, tolerability, and pharmacokinetics of a single intravenous dose in 12 healthy male participants in Belgium. The trial was randomized, double-blind, and placebo-controlled.
JNJ-49122944, 5 milligram is a dose-specific designation of the drug candidate JNJ-49122944. The 5 milligram refers to the amount administered in the clinical study. Both names refer to the same investigational compound developed by Johnson & Johnson.