HealthyPhase 1NCT02852395
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274
A Phase 1 study testing JNJ-48816274 in people with Healthy, run by Janssen-Cilag International NV at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-48816274
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 13 Aug 2016to 2 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- JNJ-48816274, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-48816274Drug
Oral dose; dose range of 5 mg up to 250 mg
PlaceboDrug
Oral dose; appearance matched to JNJ-48816274
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Single Dose | Experimental | 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. Receives: Drug: JNJ-48816274; Drug: Placebo |
| Part 2 Crossover Sleep Study | Experimental | 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). Receives: Drug: JNJ-48816274; Drug: Placebo |
| Part 3 Repeated Dose (Optional) | Experimental | 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). Receives: Drug: JNJ-48816274; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Measured: 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])
Measured: Days 1-2 in Part 1
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 in Part 1
Time to Reach the Maximum Plasma Concentration (Tmax)
Measured: Day 1 in Part 1
Elimination Half Life (t1/2)
Measured: Days 1-2 in Part 1
Mean Karolinska Sleepiness Scale score
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).
Measured: Day 1 in Part 1
Secondary outcomes (8)
Mean Total Sleep Time by 8-hour overnight Polysomnography
The sum of all minutes of sleep stages 1, 2, 3, and 4 will be assessed.
Measured: Part 2: Days 1-2 of each of 3 or 4 crossover periods
Mean Latency to Persistent Sleep by 8-hour overnight Polysomnography
Elapsed time from the beginning of the polysomnography recording to the onset of continuous sleep will be assessed.
Measured: Part 2: Days 1-2 of each of 3 or 4 crossover periods
Mean Leeds Sleep Evaluation Questionnaire (LSEQ) Score
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.
Measured: Part 2: Day 2 of each of 3 or 4 crossover periods
Mean Subjective Quality of Sleep Questionnaire (SQSQ) Item Scores
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.
Measured: Part 2: Day 2 of each of 3 or 4 crossover periods
Mean Karolinska Sleepiness Scale score
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).
Measured: 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
Evaluation of the effect of food consumption on PK of JNJ-48816274.
Measured: Part 1: Days 1-2
Correlation Between Plasma Levels of JNJ-48816274 and Karolinska Sleepiness Scale Score
Evaluation of the pharmacokinetic and pharmacodynamic relationship of JNJ-48816274 using a measure of somnolence.
Measured: 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
Evaluation of the pharmacokinetic and pharmacodynamic relationship of JNJ-48816274 using a measure of sleep
Measured: Part 2: Days 1-2 of each of 3 or 4 crossover periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start13 Aug 2016
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852395
- Sponsor's protocol ID
- CR108090
- Other IDs
- 48816274EDI1001, 2015-004186-89, 2015
- Status last verified
- Apr 2025
- First submitted
- 11 Jul 2016
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274
- ClinicalTrials.gov ID
- NCT02852395
- Acronym / sponsor ID
- CR108090
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2016 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 Single Dose | Experimental | Drug: JNJ-48816274, Drug: PlaceboPart 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 | Experimental | Drug: JNJ-48816274, Drug: PlaceboPart 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) | Experimental | Drug: JNJ-48816274, Drug: PlaceboPart 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-48816274Oral dose; dose range of 5 mg up to 250 mg | Drug | Part 1 Single Dose, Part 2 Crossover Sleep Study, Part 3 Repeated Dose (Optional) |
| PlaceboOral dose; appearance matched to JNJ-48816274 | Drug | Part 1 Single Dose, Part 2 Crossover Sleep Study, Part 3 Repeated Dose (Optional) |
Primary outcome
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)
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
Time frame: Days 1-2 in Part 1
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 in Part 1
Time to Reach the Maximum Plasma Concentration (Tmax)
Time frame: Day 1 in Part 1
Elimination Half Life (t1/2)
Time frame: 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).
8 secondary outcomes
Mean Total Sleep Time by 8-hour overnight Polysomnography
Time frame: 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
Mean Leeds Sleep Evaluation Questionnaire (LSEQ) Score
Time frame: 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
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
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
Correlation Between Plasma Levels of JNJ-48816274 and Karolinska Sleepiness Scale Score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-48816274 in people with Healthy, run by Janssen-Cilag International NV at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.