Skip to main content
OpenTrials
Completed

NCT Number: NCT02852395

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guildford, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-48816274

Drug

Oral dose; dose range of 5 mg up to 250 mg

Placebo

Drug

Oral dose; appearance matched to JNJ-48816274

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability

    Time frame: Up to 14 days after last dose in Part 1 (approximately 5.5 weeks)

  2. Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])

    Time frame: Days 1-2 in Part 1

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 1 in Part 1

  4. Time to Reach the Maximum Plasma Concentration (Tmax)

    Time frame: Day 1 in Part 1

  5. Elimination Half Life (t1/2)

    Time frame: Days 1-2 in Part 1

  6. Mean Karolinska Sleepiness Scale score

    Time frame: 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 outcomes

  1. Mean Total Sleep Time by 8-hour overnight Polysomnography

    Time frame: 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.

  2. Mean Latency to Persistent Sleep by 8-hour overnight Polysomnography

    Time frame: 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.

  3. Mean Leeds Sleep Evaluation Questionnaire (LSEQ) Score

    Time frame: 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.

  4. Mean Subjective Quality of Sleep Questionnaire (SQSQ) Item Scores

    Time frame: 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.

  5. Mean Karolinska Sleepiness Scale score

    Time frame: 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).

  6. Area Under the Plasma Concentration vs. Time Curve in Subjects who are Fasted Predose vs. Those Fed a Meal

    Time frame: Part 1: Days 1-2

    Evaluation of the effect of food consumption on PK of JNJ-48816274.

  7. Correlation Between Plasma Levels of JNJ-48816274 and Karolinska Sleepiness Scale Score

    Time frame: Day 1 of Parts 1 and 3

    Evaluation of the pharmacokinetic and pharmacodynamic relationship of JNJ-48816274 using a measure of somnolence.

  8. Correlation Between Plasma Levels of JNJ-48816274 and Duration of Sleep as Measured by 8-hour Overnight Polysomnography

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Janssen-Cilag International NV

Industry

Registry information

Official study title

A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2016
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.