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| ID | Type | Description | Link |
|---|---|---|---|
| 48816274EDI1001 | Other Identifier | Janssen-Cilag International NV | |
| 2015-004186-89 | EudraCT Number |
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This is a 3-part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-48816274 in healthy participants after administration of single and repeated doses, and to evaluate its potential effectiveness for treating insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-48816274 | Drug | Oral dose; dose range of 5 mg up to 250 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Up to 14 days after last dose in Part 1 (approximately 5.5 weeks) | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) | Days 1-2 in Part 1 | |
| Maximum Observed Plasma Concentration (Cmax) | Day 1 in Part 1 | |
| Time to Reach the Maximum Plasma Concentration (Tmax) | Day 1 in Part 1 | |
| Elimination Half Life (t1/2) | Days 1-2 in Part 1 | |
| Mean Karolinska Sleepiness Scale score | 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). | Day 1 in Part 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Total Sleep Time by 8-hour overnight Polysomnography | The sum of all minutes of sleep stages 1, 2, 3, and 4 will be assessed. | Part 2: Days 1-2 of each of 3 or 4 crossover periods |
| Mean Latency to Persistent Sleep by 8-hour overnight Polysomnography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guildford | United Kingdom | |||||
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| Placebo | Drug | Oral dose; appearance matched to JNJ-48816274 |
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Elapsed time from the beginning of the polysomnography recording to the onset of continuous sleep will be assessed. |
| Part 2: Days 1-2 of each of 3 or 4 crossover periods |
| Mean Leeds Sleep Evaluation Questionnaire (LSEQ) Score | A participant-reported 10-item visual analogue scale used to rate the quality of sleep. A 100 millimeter (mm) line used for ratings, with higher scores representing better sleep-wake characteristics. | Part 2: Day 2 of each of 3 or 4 crossover periods |
| Mean Subjective Quality of Sleep Questionnaire (SQSQ) Item Scores | A participant-reported 10-item questionnaire to estimate the time to fall asleep, duration of sleep, number of awakenings, sleep quality, and feeling upon awakening. | Part 2: Day 2 of each of 3 or 4 crossover periods |
| Mean Karolinska Sleepiness Scale score | 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). | Part 2: Days 1-2 of each of 3 or 4 crossover periods; Part 3: Days 1-7 |
| Area Under the Plasma Concentration vs. Time Curve in Subjects who are Fasted Predose vs. Those Fed a Meal | Evaluation of the effect of food consumption on PK of JNJ-48816274. | Part 1: Days 1-2 |
| Correlation Between Plasma Levels of JNJ-48816274 and Karolinska Sleepiness Scale Score | Evaluation of the pharmacokinetic and pharmacodynamic relationship of JNJ-48816274 using a measure of somnolence. | Day 1 of Parts 1 and 3 |
| Correlation Between Plasma Levels of JNJ-48816274 and Duration of Sleep as Measured by 8-hour Overnight Polysomnography | Evaluation of the pharmacokinetic and pharmacodynamic relationship of JNJ-48816274 using a measure of sleep | Part 2: Days 1-2 of each of 3 or 4 crossover periods |
| United Kingdom |
| United Kingdom |