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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02852395 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274 | PHASE1 | COMPLETED | 90 | — | — | Aug 13, 2016 | May 2, 2018 | Apr 27, 2025 | 2 | United Kingdom |
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...