Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-42165279 2.5 · 1 trial · 2 indications
As a measure of safety.
Cmax is defined as maximum plasma concentration of JNJ-42165279.
AUC is defined area under the plasma concentration time curve from 0 to t hours post dosing of JNJ-42165279.
| Arm | Type | Description |
|---|---|---|
| Part 1 - Panel 1 | EXPERIMENTAL | The participants will receive 3 or 4 ascending doses (2.5, 10, 30, 100, 250, 500 mg) of JNJ-42165279 and placebo during the study. |
| Part 1 - Panel 2 | EXPERIMENTAL | The participants will receive 3 or 4 ascending doses (2.5, 10, 30, 100, 250, 500 mg) of JNJ-42165279 and placebo during the study. |
| Part 2 (parallel)- additional cohort | EXPERIMENTAL | The participants will receive repeated daily dosing of 100 mg JNJ-42165279 or placebo for 6 consecutive days. |
| Name | Type | Description |
|---|---|---|
| JNJ-42165279 2.5 - 500 mg oral | DRUG | Type=exact number, unit=mg, numbers=2.5, 10, 30, 100, 250 and 500, form=suspension, route=oral use. One single dose administered orally. |
| Placebo | DRUG | Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally. |
| JNJ-42165279 100 mg oral | DRUG | Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally. |
Inclusion Criteria: * Has a body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg. * Must adhere to required contraception (subject and partner, if applicable) during the study and for 3 months after study * Must agree to not donate sperm during the study and for 3 months afte...
JNJ-42165279 2.5 is an investigational small molecule being studied in healthy volunteers. It is being evaluated for safety, tolerability, and pharmacokinetics, which is how the drug is absorbed, distributed, metabolized, and eliminated by the body. It is not approved for any disease and is in early clinical development.
JNJ-42165279 2.5 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile in healthy participants.
JNJ-42165279 2.5 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial is complete and was designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy male participants.
JNJ-42165279 2.5 has one completed clinical trial, identified as NCT01650597. This was a single ascending dose study conducted in Belgium to investigate the safety, tolerability, and pharmacokinetics of the drug in healthy male participants. The trial enrolled 29 participants and was randomized, double-blind, and controlled.
JNJ-42165279 2.5 is a version of the investigational compound JNJ-42165279. The '2.5' designation likely refers to a specific formulation or dose strength being studied. In the clinical trial NCT01650597, the drug is referred to as JNJ-42165279, and the 2.5 version is being evaluated for its safety and pharmacokinetic profile.