Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-27 @ 9:28 AM
Study NCT ID:
NCT02852395
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2016-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2016-07-11', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': "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)."}], 'secondaryOutcomes': [{'measure': 'Mean Total Sleep Time by 8-hour overnight Polysomnography', 'timeFrame': 'Part 2: Days 1-2 of each of 3 or 4 crossover periods', 'description': 'The sum of all minutes of sleep stages 1, 2, 3, and 4 will be assessed.'}, {'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', 'description': 'Elapsed time from the beginning of the polysomnography recording to the onset of continuous sleep will be assessed.'}, {'measure': 'Mean Leeds Sleep Evaluation Questionnaire (LSEQ) Score', 'timeFrame': 'Part 2: Day 2 of each of 3 or 4 crossover periods', 'description': '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.'}, {'measure': 'Mean Subjective Quality of Sleep Questionnaire (SQSQ) Item Scores', 'timeFrame': 'Part 2: Day 2 of each of 3 or 4 crossover periods', 'description': '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.'}, {'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', 'description': "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)."}, {'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', 'description': 'Evaluation of the effect of food consumption on PK of JNJ-48816274.'}, {'measure': 'Correlation Between Plasma Levels of JNJ-48816274 and Karolinska Sleepiness Scale Score', 'timeFrame': 'Day 1 of Parts 1 and 3', 'description': 'Evaluation of the pharmacokinetic and pharmacodynamic relationship of JNJ-48816274 using a measure of somnolence.'}, {'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', 'description': 'Evaluation of the pharmacokinetic and pharmacodynamic relationship of JNJ-48816274 using a measure of sleep'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be healthy as assessed by medical history and safety evaluations performed at screening\n* Has a body mass index between 18 and 30 kilogram per square meter (kg/m2) and body weight not less than 50 kg\n* Must be willing and able to abide by the prohibitions and restrictions of the study, including requirements for contraception\n* Women must not be of childbearing potential by either being postmenapausal or permanently sterilized\n* Part 2 Only: Maintains a regular sleep-wake cycle as measured by sleep diaries and a watch that measures activity\n* Has a habitual (majority of days) bedtime and duration of sleep that meet the study requirements\n\nExclusion Criteria:\n\n* Current or history of clinically significant medical or psychiatric illness, or recent major surgery or blood loss/donation\n* Any current sleep-wake disorder, recent night shift work, or history of insomnia within the last 5 years\n* Man who has a pregnant female partner\n* Woman who is breastfeeding\n* Is participating or has participated within the last 3 months in a study with an investigational drug or medical device\n* Tests positive or has a history of human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or other active liver disease\n* 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\n* Routinely consumes an excessive amount of caffeine'}, 'identificationModule': {'nctId': 'NCT02852395', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag International NV'}, 'officialTitle': 'A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274', 'orgStudyIdInfo': {'id': 'CR108090'}, 'secondaryIdInfos': [{'id': '48816274EDI1001', 'type': 'OTHER', 'domain': 'Janssen-Cilag International NV'}, {'id': '2015-004186-89', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Single Dose', 'description': '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.', 'interventionNames': ['Drug: JNJ-48816274', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Crossover Sleep Study', 'description': '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).', 'interventionNames': ['Drug: JNJ-48816274', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 Repeated Dose (Optional)', 'description': '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).', 'interventionNames': ['Drug: JNJ-48816274', 'Drug: Placebo']}], 'interventions': [{'name': 'JNJ-48816274', 'type': 'DRUG', 'description': 'Oral dose; dose range of 5 mg up to 250 mg', 'armGroupLabels': ['Part 1 Single Dose', 'Part 2 Crossover Sleep Study', 'Part 3 Repeated Dose (Optional)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral dose; appearance matched to JNJ-48816274', 'armGroupLabels': ['Part 1 Single Dose', 'Part 2 Crossover Sleep Study', 'Part 3 Repeated Dose (Optional)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guildford', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'city': 'United Kingdom', 'country': 'United Kingdom'}], 'overallOfficials': [{'name': 'Janssen-Cilag International NV Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen-Cilag International NV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen-Cilag International NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}