Clinical trial NCT02852395: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274
Official title: A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2016-08-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 14 days after last dose in Part 1 (approximately 5.5 weeks)
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
timeFrame: Days 1-2 in Part 1
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 in Part 1
measure: Time to Reach the Maximum Plasma Concentration (Tmax)
timeFrame: Day 1 in Part 1
measure: Elimination Half Life (t1/2)
timeFrame: Days 1-2 in Part 1
measure: Mean Karolinska Sleepiness Scale score
timeFrame: Day 1 in Part 1
Secondary outcomes:
measure: Mean Total Sleep Time by 8-hour overnight Polysomnography
timeFrame: Part 2: Days 1-2 of each of 3 or 4 crossover periods
measure: Mean Latency to Persistent Sleep by 8-hour overnight Polysomnography
timeFrame: Part 2: Days 1-2 of each of 3 or 4 crossover periods
measure: Mean Leeds Sleep Evaluation Questionnaire (LSEQ) Score
timeFrame: Part 2: Day 2 of each of 3 or 4 crossover periods
measure: Mean Subjective Quality of Sleep Questionnaire (SQSQ) Item Scores
timeFrame: Part 2: Day 2 of each of 3 or 4 crossover periods
measure: Mean Karolinska Sleepiness Scale score
timeFrame: Part 2: Days 1-2 of each of 3 or 4 crossover periods; Part 3: Days 1-7
measure: Area Under the Plasma Concentration vs. Time Curve in Subjects who are Fasted Predose vs. Those Fed a Meal
timeFrame: Part 1: Days 1-2
measure: Correlation Between Plasma Levels of JNJ-48816274 and Karolinska Sleepiness Scale Score
timeFrame: Day 1 of Parts 1 and 3
measure: Correlation Between Plasma Levels of JNJ-48816274 and Duration of Sleep as Measured by 8-hour Overnight Polysomnography
timeFrame: Part 2: Days 1-2 of each of 3 or 4 crossover periods
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
city: United Kingdom
country: United Kingdom
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: