Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-54416076 · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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.
Tmax is the actual sampling time to reach the maximum observed concentration.
The AUC24h is the area under the concentration versus time curve (AUC) from time of administration up to 24 hours post dosing.
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
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.
The elimination half-life (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 slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Total clearance of drug after extravascular administration, uncorrected for absolute bioavailability, calculated as: Dose (D)/AUC (0-infinity).
The Vd/F is defined as Dose/\[Lambda (z)\*AUC (0-infinity)\].
Cmax is the maximum observed concentration.
| Arm | Type | Description |
|---|---|---|
| JNJ-54416076 | EXPERIMENTAL | Participants will receive single dose of JNJ-54416076 (in ascending dose) in Part 1 and 2 doses of JNJ-54416076 (one dose in the fasted state and an identical dose in the fed state) in Part 2. The dose selected for Part 2 will be selected based on the preliminary safety and PK data in Part 1. |
| Placebo | EXPERIMENTAL | Participants will receive single dose of placebo in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-54416076 | DRUG | JNJ-54416076 suspension will be administered orally. |
| Placebo | DRUG | Placebo solution will be administered orally. |
Inclusion Criteria: * Body Mass Index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m\^2) (inclusive) and body weight greater than or equal to (\>=) 50 kg * Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogr...
JNJ-54416076 is an investigational small molecule drug being developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy participants, and no therapeutic indication has been disclosed for the compound.
JNJ-54416076 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 study of the compound conducted in Germany.
JNJ-54416076 is in Phase 1 development. One Phase 1 trial has been completed, and no later-stage trials have been recorded. The compound is investigational and has not been approved by the FDA for any indication.
JNJ-54416076 was evaluated in a single Phase 1 trial, NCT02670395, titled A Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-54416076 in Healthy Participants. The completed study enrolled 64 healthy male volunteers in Germany.
The Phase 1 trial NCT02670395 was a randomized, double-blind, controlled study of JNJ-54416076 in healthy male volunteers aged 18 years and older. It enrolled 64 participants in Germany and assessed safety, tolerability, food effect, and pharmacokinetics. The study is completed.