Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-29 @ 12:24 AM
Study NCT ID:
NCT02603861
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2015-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3154207 on Sleep in Healthy Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707472', 'term': 'LY3154207'}, {'id': 'D000077408', 'term': 'Modafinil'}], 'ancestors': [{'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-04', 'studyFirstSubmitDate': '2015-11-11', 'studyFirstSubmitQcDate': '2015-11-11', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Sleep Onset', 'timeFrame': 'Day 1: 2 hours post dose through 8 hours post dose in each period.'}], 'secondaryOutcomes': [{'measure': 'Maximum Concentration (Cmax) of LY3154207', 'timeFrame': 'Day 1: 1 hour post dose through 24 hours post dose in each period.'}, {'measure': 'Area Under the Concentration Versus Time Curve (AUC) of LY3154207', 'timeFrame': 'Day 1: 1 hour post dose through 24 hours post dose in each period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of single doses of LY3154207 on the amount of time it takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much LY3154207 gets into the blood stream and how long it takes the body to remove it. Information about any side effects that occur will be collected. Each participant will complete four study periods, which will last a total of about 8 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overtly healthy males 18 years of age or older who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n* Have a regular sleep pattern with routine time spent in bed between 6.5 hours and 9 hours each night\n\nExclusion Criteria:\n\n* Are shift workers who shifted work within 14 days prior to screening or plan to during the study\n* Have a known sleep disorder or history of a sleep disorder\n* Have traveled 2 time zones or more within 7 days prior to screening or plan to during the study\n* Regularly take naps during the day\n* Are hearing impaired'}, 'identificationModule': {'nctId': 'NCT02603861', 'briefTitle': 'A Study of LY3154207 on Sleep in Healthy Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Evaluation of the Impact of Single Doses of LY3154207 on Sleep Latency in Sleep-Deprived Healthy Subjects', 'orgStudyIdInfo': {'id': '15511'}, 'secondaryIdInfos': [{'id': 'I7S-EW-HBEB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matching LY3154207 administered once orally in one of four periods.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3154207 - Dose 1', 'description': 'LY3154207 administered orally in no more than one of the four periods.', 'interventionNames': ['Drug: LY3154207']}, {'type': 'EXPERIMENTAL', 'label': 'LY3154207 - Dose 2', 'description': 'LY3154207 administered orally in no more than one of the four periods.', 'interventionNames': ['Drug: LY3154207']}, {'type': 'EXPERIMENTAL', 'label': 'LY3154207 - Dose 3', 'description': 'LY3154207 administered orally in no more than one of the four periods.', 'interventionNames': ['Drug: LY3154207']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modafinil', 'description': '200 mg modafinil administered orally in no more than one of the four periods.', 'interventionNames': ['Drug: Modafinil']}], 'interventions': [{'name': 'LY3154207', 'type': 'DRUG', 'description': 'LY3154207 administered orally.', 'armGroupLabels': ['LY3154207 - Dose 1', 'LY3154207 - Dose 2', 'LY3154207 - Dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered orally.', 'armGroupLabels': ['Placebo']}, {'name': 'Modafinil', 'type': 'DRUG', 'description': 'Modafinil administered orally.', 'armGroupLabels': ['Modafinil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Parexel Early Phase Unit at Glendale', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}