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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 developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United Kingdom. The specific disease or condition it is intended to treat has not been publicly disclosed.
JNJ-48816274 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound carries the company's JNJ designation, indicating it is an internal Johnson & Johnson research asset.
JNJ-48816274 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound remains investigational and has not been approved by the FDA or any other regulatory agency.
JNJ-48816274 was evaluated in a single Phase 1 trial, NCT02852395, titled a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-48816274. The trial enrolled 90 healthy adult volunteers in the United Kingdom, was randomized, double-blind, and controlled, and is now completed.
The Phase 1 trial NCT02852395 was a randomized, double-blind, controlled study conducted in the United Kingdom. It enrolled 90 healthy volunteers aged 18 years and older, with both sexes eligible. The study assessed safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-48816274 and has been completed.