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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02623491 | Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Participants | PHASE1 | COMPLETED | 175 | — | — | Nov 1, 2015 | Sep 1, 2016 | Dec 6, 2016 | 1 | Belgium |
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
The Tmax is defined as actual sampling time to reach maximum observed concentration.
The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
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).
The Cmax is the maximum observed concentration.
The Tmax is defined as actual sampling time to reach maximum observed concentration.
The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
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).
The Cmax is the maximum observed concentration.
| Arm | Type | Description |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | EXPERIMENTAL | Participants will receive 0.75 milligrams (mg) of JNJ-55375515 (starting dose) or Placebo on Day 1. Dose of the study medication will be escalated sequentially up to a maximum of 200 mg. |
| Part 2: Multiple Ascending Dose (MAD) | EXPERIMENTAL | Participants will receive JNJ-55375515 (at doses determined based on the data from the SAD part) or Placebo from Day 1 to 10. |
| Name | Type | Description |
|---|---|---|
| JNJ-55375515 | DRUG | Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg. |
| Placebo | DRUG | Participants will receive matching placebo. |
Inclusion Criteria: * Participant must be healthy on the basis of physical and neurological examination, medical history, vital signs, and electrocardiogram (ECG), and have a body mass index of 18-30 kilogram / square meter (kg/m\^2) and a body mass of not less than 50 kg. * Participant must be hea...