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ML Risk
JNJ-48816274 · 1 trial · 1 indication
A 1-item questionnaire completed by participants to rate their degree of sleepiness on a scale of 1 to 9, ranging from 'extremely alert' (1) to 'very sleepy, great effort to keep awake, fighting sleep' (9).
| Arm | Type | Description |
|---|---|---|
| Part 1 Single Dose | EXPERIMENTAL | Part 1 single daytime oral dose of JNJ-48816274 or placebo. Doses of JNJ-48816274 will start at 5 milligram (mg) and increase sequentially to a maximum dose of 250 mg. |
| Part 2 Crossover Sleep Study | EXPERIMENTAL | Part 2 single nighttime oral dose of JNJ-48816274 or placebo administered during each of 3 or 4 crossover periods separated by 7-9 days. The doses of JNJ-48816274 will be selected based on data from Part 1 (not to exceed 250 mg). |
| Part 3 Repeated Dose (Optional) | EXPERIMENTAL | Part 3 daytime oral dose of JNJ-48816274 or placebo administered once daily for 7 consecutive days. Doses will be determined based on data from Part 1, and may increase sequentially (not to exceed 250 mg/day). |
| Name | Type | Description |
|---|---|---|
| JNJ-48816274 | DRUG | Oral dose; dose range of 5 mg up to 250 mg |
| Placebo | DRUG | Oral dose; appearance matched to JNJ-48816274 |
Inclusion Criteria: * Must be healthy as assessed by medical history and safety evaluations performed at screening * Has a body mass index between 18 and 30 kilogram per square meter (kg/m2) and body weight not less than 50 kg * Must be willing and able to abide by the prohibitions and restrictions...
JNJ-48816274 is an investigational small molecule being developed by Johnson & Johnson. It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.
JNJ-48816274 is being studied for use in healthy volunteers. It is an investigational small molecule in Phase 1 clinical development. The ongoing research aims to evaluate the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in this population.
JNJ-48816274 is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker JNJ. The drug is currently in Phase 1 clinical development.
JNJ-48816274 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers.
JNJ-48816274 has one completed clinical trial, identified as NCT02852395. This Phase 1 study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in 90 healthy volunteers in the United Kingdom. The trial was randomized, double-blind, and controlled.