A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274
- Registration Number
- NCT02852395
- Lead Sponsor
- Janssen-Cilag International NV
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Single Dose Placebo 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 1 Single Dose JNJ-48816274 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 Placebo 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) JNJ-48816274 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). Part 3 Repeated Dose (Optional) Placebo 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). Part 2 Crossover Sleep Study JNJ-48816274 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).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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).
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
Trial Locations
- Locations (2)
University of Surrey
🇬🇧Guildford, United Kingdom
Quotient Clinical Limited
🇬🇧United Kingdom, United Kingdom