Healthy
Conditions
Brief summary
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.
Interventions
DRUGJNJ-48816274
Oral dose; dose range of 5 mg up to 250 mg
DRUGPlacebo
Oral dose; appearance matched to JNJ-48816274
Sponsors
Janssen-Cilag International NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 of the study, including requirements for contraception * Women must not be of childbearing potential by either being postmenapausal or permanently sterilized * Part 2 Only: Maintains a regular sleep-wake cycle as measured by sleep diaries and a watch that measures activity * Has a habitual (majority of days) bedtime and duration of sleep that meet the study requirements
Exclusion criteria
* Current or history of clinically significant medical or psychiatric illness, or recent major surgery or blood loss/donation * Any current sleep-wake disorder, recent night shift work, or history of insomnia within the last 5 years * Man who has a pregnant female partner * Woman who is breastfeeding * Is participating or has participated within the last 3 months in a study with an investigational drug or medical device * Tests positive or has a history of human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or other active liver disease * Drug or alcohol abuse within the last 5 years, nicotine use within the last 3 months, or tests positive for alcohol, drugs of abuse, or nicotine * Routinely consumes an excessive amount of caffeine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1 in Part 1 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Plasma Levels of JNJ-48816274 and Karolinska Sleepiness Scale Score | Day 1 of Parts 1 and 3 | Evaluation of the pharmacokinetic and pharmacodynamic relationship of JNJ-48816274 using a measure of somnolence. |
| Mean Total Sleep Time by 8-hour overnight Polysomnography | Part 2: Days 1-2 of each of 3 or 4 crossover periods | The sum of all minutes of sleep stages 1, 2, 3, and 4 will be assessed. |
| Correlation Between Plasma Levels of JNJ-48816274 and Duration of Sleep as Measured by 8-hour Overnight Polysomnography | Part 2: Days 1-2 of each of 3 or 4 crossover periods | Evaluation of the pharmacokinetic and pharmacodynamic relationship of JNJ-48816274 using a measure of sleep |
| Mean Latency to Persistent Sleep by 8-hour overnight Polysomnography | Part 2: Days 1-2 of each of 3 or 4 crossover periods | Elapsed time from the beginning of the polysomnography recording to the onset of continuous sleep will be assessed. |
| Mean Leeds Sleep Evaluation Questionnaire (LSEQ) Score | Part 2: Day 2 of each of 3 or 4 crossover periods | 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. |
| Mean Subjective Quality of Sleep Questionnaire (SQSQ) Item Scores | Part 2: Day 2 of each of 3 or 4 crossover periods | 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. |
| Mean Karolinska Sleepiness Scale score | Part 2: Days 1-2 of each of 3 or 4 crossover periods; Part 3: Days 1-7 | 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). |
| Area Under the Plasma Concentration vs. Time Curve in Subjects who are Fasted Predose vs. Those Fed a Meal | Part 1: Days 1-2 | Evaluation of the effect of food consumption on PK of JNJ-48816274. |
Countries
United Kingdom
Outcome results
None listed