Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852395
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-48816274 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274
Actual Study Start Date : August 13, 2016
Actual Primary Completion Date : May 2, 2018
Actual Study Completion Date : May 2, 2018

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852395


Locations
Layout table for location information
United Kingdom
University of Surrey
Guildford, United Kingdom, GU2 7XP
Quotient Clinical Limited
United Kingdom, United Kingdom, NG11 6JS
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
Layout table for investigator information
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
Layout table for additonal information
Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT02852395    
Other Study ID Numbers: CR108090
48816274EDI1001 ( Other Identifier: Janssen-Cilag International NV )
2015-004186-89 ( EudraCT Number )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No