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

April 25, 2025 updated by: Janssen-Cilag International NV

A First-in-Human 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Guildford, United Kingdom
      • United Kingdom, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 Single Dose
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.
Drug: JNJ-48816274
Oral dose; dose range of 5 mg up to 250 mg
Drug: Placebo
Oral dose; appearance matched to JNJ-48816274
Experimental: Part 2 Crossover Sleep Study
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).
Drug: JNJ-48816274
Oral dose; dose range of 5 mg up to 250 mg
Drug: Placebo
Oral dose; appearance matched to JNJ-48816274
Experimental: Part 3 Repeated Dose (Optional)
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).
Drug: JNJ-48816274
Oral dose; dose range of 5 mg up to 250 mg
Drug: Placebo
Oral dose; appearance matched to JNJ-48816274

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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])
Time Frame: Days 1-2 in Part 1
Days 1-2 in Part 1
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 1 in Part 1
Day 1 in Part 1
Time to Reach the Maximum Plasma Concentration (Tmax)
Time Frame: Day 1 in Part 1
Day 1 in Part 1
Elimination Half Life (t1/2)
Time Frame: Days 1-2 in Part 1
Days 1-2 in Part 1
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).
Day 1 in Part 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Part 2: Days 1-2 of each of 3 or 4 crossover periods
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.
Part 2: Days 1-2 of each of 3 or 4 crossover periods
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.
Part 2: Day 2 of each of 3 or 4 crossover periods
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.
Part 2: Day 2 of each of 3 or 4 crossover periods
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).
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
Time Frame: Part 1: Days 1-2
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
Time Frame: Day 1 of Parts 1 and 3
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
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
Part 2: Days 1-2 of each of 3 or 4 crossover periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag International NV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen-Cilag International NV Clinical Trial, Janssen-Cilag International NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108090
  • 48816274EDI1001 (Other Identifier: Janssen-Cilag International NV)
  • 2015-004186-89 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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