Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-28 @ 4:08 AM
Study NCT ID:
NCT01673451
Status:
COMPLETED
Last Update Posted:
2013-10-11
First Post:
2012-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-10', 'studyFirstSubmitDate': '2012-08-21', 'studyFirstSubmitQcDate': '2012-08-23', 'lastUpdatePostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse events (AEs)', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Plasma concentrations of E2006', 'timeFrame': 'Part A up to 288 hours postdose; Part B: up to 324 hours postdose'}]}, 'conditionsModule': {'keywords': ['insomnia'], 'conditions': ['CNS']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, double-blind, placebo-controlled, sequential, multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening dosing).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Included:\n\n* Healthy males or females, ages 18 to 55 years (Part A) or 65 to 80 years (Part B)\n* Who report typical time in bed 7.5 to 9 hours\n* Who report typical bedtime 22:00 - 24:00 and typical wake time 06:00 - 08:00\n* Who report typical sleep latency of \\<= 30 minutes\n* All females must be of non-childbearing potential, or subjects who have been sterilized surgically or who are otherwise proven sterile. Females must have a negative serum beta-human chorionic gonadotropin (Beta-hCG) test result at Screening and a negative urine pregnancy test at Baseline.\n* Body mass index BMI \\> 18 and 32 kg/m2 at Screening\n\nExcluded:\n\n* Performed shift work within 2 weeks prior to Screening\n* Had taken a flight across three or more time zones in the 7 days prior to Screening\n* Female subjects who are nursing\n* With a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profile of E2006\n* With a known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy\n* Hypersensitivity to the study drug or any of the excipients'}, 'identificationModule': {'nctId': 'NCT01673451', 'briefTitle': '2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of E2006 in Healthy Adult and Elderly Subjects', 'orgStudyIdInfo': {'id': 'E2006-A001-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo comparator', 'interventionNames': ['Drug: Placebo comparator']}, {'type': 'EXPERIMENTAL', 'label': 'E2006', 'interventionNames': ['Drug: E2006']}], 'interventions': [{'name': 'E2006', 'type': 'DRUG', 'description': 'Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules', 'armGroupLabels': ['E2006']}, {'name': 'Placebo comparator', 'type': 'DRUG', 'description': 'E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules', 'armGroupLabels': ['Placebo comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90232', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'Parexel, California Clinical Trials', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'overallOfficials': [{'name': 'Dohwa Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parexel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}