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 is an investigational small molecule being studied in healthy volunteers. It is not intended for a specific disease indication; rather, it is being evaluated in a Phase 1 clinical trial to assess its safety, tolerability, and pharmacokinetics after a single intravenous dose.
JNJ-49122944 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research on this investigational small molecule.
JNJ-49122944 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The single completed Phase 1 trial focused on healthy male participants to evaluate safety, tolerability, and pharmacokinetics.
JNJ-49122944 has one completed clinical trial, registered as NCT02280018. This Phase 1 study was a safety, tolerability, and pharmacokinetics study of a single intravenous dose in healthy male participants. The trial was conducted in Belgium and enrolled 12 participants.
JNJ-49122944 is the drug name, and 5 milligram refers to a specific dosage strength being studied. The clinical trial NCT02280018 evaluated a single intravenous dose of JNJ-49122944, with the 5 milligram dose being one of the doses tested in the study.